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Jobs that Crossed my Desk –Oct. 4-12, 2008 BioSpace Biotech Bay Career Fair, Tuesday Afternoon, Oct. 14, 2008 Topic: Biotech Bay Career Fair with Leading Pharma and Biotech Companies Date and Time: Tuesday, Oct. 14, 2008, 2-7 pm Location: San Francisco Airport Marriott, Burlingame, CA You must pre-register to attend. Do not miss the chance to interview with the biopharmaceutical industry's most prestigious companies! All candidates must have at least a four-year college degree and two years of industry related work experience to attend. (Equivalent work experience may be considered in lieu of a four-year college degree.) Qualified candidates will receive their invitations and confirmation numbers via email no later than 72 hours prior to the career fair. Pre-screened and accepted candidates must bring a copy of their invitation with confirmation number to the event. Register at http://careers.biospace.com/Jobs/Public/CareerFairPreReg.aspx?RECEPTION_ID=154 BioSpace Career Fair [email protected] 2399 Highway 34, Bldg A-5Manasquan, NJ 08736 ***************************************************** Contact the person whose information appears at the top of each listing. ***************************************************** Qualified applicants should contact [email protected] Julie Bukar [email protected]; www.JGBBioPharma.com JOB DESCRIPTIONS Title: Medical Device Software Development Engineer Reports To: Director, Device Development & Project Management Department: Development Summary and Scope of Position: Successful candidate will be responsible for the development and product support activities for the instrument software. Candidate will develop programming solutions for new instrument, and work with partners and contract manufacturers to support current product software and interface needs in the EU and US. 5/5/2017 1 Primary Responsibilities: • Evaluate alternative programming solutions and translate options into new development or maintenance implementations. • Verify and validate the QNX treatment process control code and the instrument interface to current GMP regulations and ISO standards. • Provide support for installed systems, problem solving with respect to improvements, corrections and implementation of code changes, interface upgrades, and communication protocols. • Serve as primary interface with external suppliers and contract manufacturers. • Clearly and completely document the operation and design of system development through general functional requirements and detailed design documents. • Develop and debug software, including but not limited to QNX, as described in design documents. • Basic Project Management, including responsibility for meeting project budgets, timelines, and goals. • Document the operation and design of system. • Participate as a member on cross functional product development teams. Qualifications/Requirements/Skills: • BS or MS in Computer Science, Engineering or related discipline with a minimum of 5 years related experience. • Superior knowledge of all phases of system development life cycle, rapid application development methodology preferred. • Experience in QSRs and design control for a medical software environment to meet GMPs / ISO 13485 and 21 CFRs / validations. • Skilled in Real Time Operating System, deterministic multitasking environment, message queues, mutexes to avoid resource collision, semaphores, priority inversions, process prioritization are essential. • C++ and UML experience necessary. QNX knowledge preferred Linux or UNIX experience helpful, Photon microGUI experience would be an advantage. • Experience writing Interrupt routines, system signal processing, device drivers. Some shell scripting and configuration management. • Comfortable in the hardware/software interface; reading schematics and writing software to interface with peripheral devices. • Strong communication skills, including ability to write clear and concise technical procedures and reports. • Demonstrated success in working with suppliers and contract 5/5/2017 2 manufacturers. _________________________ Title: Medical Device Hardware Development Engineer Reports To: Director, Device Development & Project Management Department: Development Summary and Scope of Position: Successful candidate will be responsible for the development and product support activities for the instrument hardware. Candidate will develop engineering solutions for new instrument, and work with partners and contract manufacturers to support current product hardware and operational needs in the EU and US. Primary Responsibilities: • Evaluate existing alternatives, customer needs, and total design space and translate into new instrument design & development or commercial instrument upgrade implementations. • Design and develop solutions to current GMP regulations and ISO standards, including verification and validation activities. • Perform troubleshooting on commercial products/process problems as related to design, components, or process. • Explore engineering alternatives for instrument upgrades, electronic troubleshooting/component replacement. • Revise and implement proposals for new product specifications or current specification modification (ECO system). • Design, document, and coordinate instrument electrical and mechanical experiments (DOE), qualifications, validations, and functional tests. • Summarize, analyze, and draw conclusions from results. • Contribute as a member on cross functional product development teams - work cooperatively with development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success. • Demonstrate product development process system knowledge through delivery of high quality results. • Operate independently to plan and schedule activities necessary to meet timelines. Qualifications/Requirements/Skills: • BS or MS in Electrical or Mechanical Engineering with a minimum of 5 years related engineering experience. 5/5/2017 3 • Minimum of 5 years experience with medical instruments required. • Experience in QSRs and design control for medical instrument environment to meet GMPs / ISO 13485 and 21 CFRs / validations. • Experience implementing testing to verify conformance to EN 61000 and ASTM standards. • Comfortable in the hardware/software interface; reading schematics and understanding interfaces with peripheral devices. • Practical experience, solid understanding of electrical principles, testing and manufacturing processes. • Excellent problem solving and trouble-shooting skills. • Excellent computer networking ability. • Familiar with the use of all common electronic test equipment including Digital Multi-Meters, oscilloscopes and safety analyzers. • Strong communication skills; including ability to write clear and concise technical procedures and reports. • Demonstrated success in working with suppliers and contract manufacturers. ***************************************************** Jim Brown Associates 15 Southwind Circle Richmond, CA 94804-7405 Phone: (510) 235-4472 FAX: (510) 235-4482 e-mail: [email protected] 1. Director of Marketing - $130-150K 2. Product Manager - $80-110K 3. Marketing Communications Manager - $65-85K Job Descriptions below. Director of Marketing Develop and implement world wide marketing strategies to achieve corporate sales objectives. Lead four person marketing management team. Reports to Vice President of World Wide Marketing. Specific Duties and Responsibilities: Identify market opportunities and mobilize resources to capitalize on them 5/5/2017 4 Drive the development of marketing materials and sales tools for the world wide market Develop and implement marketing and promotional programs, and monitor and evaluate them to determine their success Prepare launch plans for effective promotion of new products world wide Cultivate relationships with key physicians world wide Train worldwide sales and marketing teams Develop and work within program budgets Investigate new markets and provide input to product management function for new applications, products and product improvements Develop knowledge of competitive products and companies and develop marketing strategies to win against them Move company to the forefront of web marketing Coordinate world wide print and online media plan Plan world wide trade shows Approximately 25-35% travel is required including international Qualifications: 15-20 years of successful marketing or related business experience at consistently more senior levels Demonstrated leadership skills Ability to work effectively within an entrepreneurial team environment. Strong oral and written communication skills and project management skills Ability to execute against both short-term deliverables and long term strategic initiatives Successful track record in similar position BS or BA in Marketing or technical-related field MBA or other advanced degree preferred Marketing Communications Manager Develop and execute all aspects of world wide Marketing Communications including branding, customer messaging, web presence, creative assets, trade shows, conferences, marketing and collateral channel partner co-marketing. Leads four-person team. Reports to Vice President, World Wide Marketing. Specific Duties and Responsibilities: Work closely with world wide team to maintain consistency and quality of corporate brand Assist in development, modification and execution of corporate graphic standards Responsible for design, development and production of collateral, trade show materials, online advertisements, web site content, brochures, newsletters, promotional material, direct mail, partner co-marketing, presentations and multimedia 5/5/2017 5 Coordinate and negotiate the use of outside services including reviewing competitive bids, issuing purchase orders and evaluating the quality of services Track and analyse the results of marketing efforts Develop and work within program budgets Monitor and evaluate all department activities for quality, cost effectiveness and timeliness Recommend equipment and related software to improve productivity, quality and effectiveness Follow corporate and regulatory policies and procedures for all materials Develop and maintain extensive knowledge about company products, competitor products, customers and the sales process to ensure the global needs of the business are addressed Oversee the logistics of trade shows and other events Approximately 10-15% travel is required Qualifications: 7-10 years of successful marketing communications or related business experience that demonstrates the required knowledge and skill set Demonstrated initiative, teamwork and the ability to work with minimal supervision Strong oral and written communication skills and project management skills Ability to execute against both short-term deliverables and long term strategic initiatives Strong track record of leadership roles and proven ability to influence and inspire others without direct authority A balance of strategic leadership skills and the ability to be "hands-on" when needed Proven track record of delivery to tight budgets and deadlines Experience utilizing cutting edge digital media Familiarity with web and collateral strategy, production and maintenance Medical device industry experience preferred Event and trade show management experience a plus Public Relations experience a plus BS or BA in Marketing, Communications, Journalism or a related field is required MBA or other advanced degree preferred Product Manager Manage the life cycle of one or more aesthetic products from concept to obsolescence. Develop marketing strategies and tactics to meet corporate sales objectives. Reports to the Vice President of World Wide Marketing. Specific Duties and Responsibilities: Technical expert and advocate within worldwide Marketing for the respective products being managed 5/5/2017 6 Primary interface between the global market and R&D for product development, product extensions and new clinical applications Develop broad and specific knowledge of competitive products and companies and develop marketing strategies and for sales situations Drive the development of ads, literature, technical papers, videos and all collateral materials Develop, implement, monitor and evaluate sales and promotional programs to determine their success Serve as product trainer for worldwide sales and marketing teams Prepare extensive launch packages for effective promotion of new products Work directly with key physicians to cultivate medical community relationships and monitor clinical sites/clinical research to help obtain data in order to achieve product goals Develop and work within program budgets Investigate new markets and propose new products within those markets Identify trends throughout the medical marketplace, especially, but not limited to laser Other duties and responsibilities as directed by supervisor Approximately 20-25% travel is required Qualifications: 3-7 years technical product management or other relevant experience Excellent written, verbal, organizational and analytical skills Demonstrated decision-making and project management skills, initiative, teamwork and success in other work related experiences Possess a strong ability to work independently under tight deadlines BS or BA in Marketing or technical-related field or equi Position Title: Associate Director, Marketing Department: Marketing Location: San Francisco Bay Area Reports to: Director, Commercial Operations Summary: The incumbent is responsible for managing all aspects of product marketing for an innovative, key promoted pharmaceutical brand under the direction and leadership of senior commercial management. Reporting to the Director, Commercial Operations, the incumbent will be accountable for developing and executing highly effective, results-driven marketing initiatives to maximize product opportunities and revenues in key therapeutic areas. Primary Responsibilities: corporate objectives. This will include the following: 5/5/2017 7 return within target therapeutic area. indications. target therapeutic areas and determine appropriate courses of action to meet or exceed objectives. members. ize impact with target customers. -disciplinary teams to provide perspective on cross-functional issues (i.e. Business Development, Clinical Development, Medical Affairs, Sales). d Regional Sales Meetings to drive brand objectives and maintain a highly motivated sales team. eness of resources and funds. developmental process for product managers within his/her department. Requirements: managing teams and direct reports. -starter with strong decision-making capabilities and demonstrated problem solving skills. ***************************************************** If you are interested, please send me your resume. I will put it to the right hiring hands. Charmaine Qiu [email protected] Our client, a leading Biotech Company in the North San Jose area, is seeking a Senior Scientist/Chemical Engineer for a long term assignment! This position will be reporting to the Advanced Technology Group: Description: Senior Chemist/Biochemist/Chemical Engineer who will both work hands-on and manage a 5/5/2017 8 small team responsible for the development of disposable immunoassay cassettes and devices for diagnostic and biomedical applications. Key responsibilities will include formulation, preparation and drying of biological reagents and various assay components in disposable assay cassettes. Controlled release re-hydration is another important part of the project. The candidate will be expected to help improve performance of existing designs and establish quality control protocols. Requirements: Applicant must have a strong immunoassay development background and hands-on experience in reagent formulation in various matrices for immunoassay applications. The ideal candidate will also have experience in dissolvable matrices and films, controlled releases of reagents and their application to microfluidic devices. Previous experience working with human blood and other biological samples is very desirable. Education/Experience: This position requires a PhD in Chemistry or Chemical Engineering, or a related field and at least 8 years experience related to assay development. Experience in managing small, focused R&D teams also required. ***************************************************** Darshana Nadkarni Please send resume as an attachment to [email protected] Orthopedic surgery company located in California, has an immediate opening for Clinical Support and Training Specialist who will report to Training Manager. Requirements include: Proficiency with 3D modeling software, working knowledge of orthopedic surgery and orthopedic planning as a controlled process, experience with orthopedic planning systems and surgical navigation systems, familiarity with hospital operating room procedures and practices, familiarity with medical production processes including machining, molding, die-casting, extrusions, sheet metal, plastics, sterile / non-sterile packaging etc., understanding of product development process, from concept to launch, experience with document control systems, and hands-on surgical robotics experience. Also required, B.S. in Engineering, 1-2 years clinical support experience, and 1 year prior direct customer training experience. ***************************************************** Andrew Youngelson [email protected] Key Recruit Inc. 5/5/2017 9 www.keyrecruit.com Sr Manager, Regulatory Date Posted: 10/7/2008 Job Id: 1653 Company: We are a privately held technology driven company. We lead the way in the development and commercialization of a conservational and renewable transportation fuel. We also provide custom-made enzymes for use within the health and nutrition markets. Location: Southern CA Reports To: Director Regulatory Salary: 110-130K Education: B.S. or M.S. in Biology or related field. Requirements: 5+ years experience in Regulatory Affairs with preferably some prior experience in the biotech industry. Familiarity with the food industry/ chem. industry and with biotech as opposed to pharma industry and biotech. Duties: Sr Manager, Regulatory will assume a leadership role in the development of regulatory submissions for company products across business units. Develop Regulatory strategy and timelines to assure high-quality and on-time regulatory submissions. Participate on Product Development teams. Interact with and provide regulatory support to QA/QC, Manufacturing, Process Development, Business Development and Product Managers. Maintain Document Control system for pertinent regulatory documents. Knowledge of FDA food regulations, food cGMPs, EPA TSCA regulations, and NIH Guidelines is desirable. As always thanks for passing on! Visit www.keyrecruit.com to view other openings. ***************************************************** Ed Bertolas Ed Bertolas Associates Inc www.ebertolasinc.com Vice President of Sales Company: Our company produces and distributes a wide variety of blood flow measurement devices for 5/5/2017 10 surgery, dialysis and medical research, and offers entrenched flow measurement resolutions to producers of medical devices. Our equipment is used in medical centers and hospitals globally to give instant, quantitative flow results during cardiac, transplant, peripheral vascular and cerebrovascular surgeries. Reports To: President Salary: 100 to 120K + 20% bonus Education: 4 year related degree Requirements: 7 years of experience in Medical Product Sales, 4 years in a senior sales or marketing management position and a proven track record of selling ability and interpersonal skills with executive level customers and partners. Duties: The VP of sales is responsible for the direction and management of all sales and sales account development operations in the USA, Canada and portions of Europe and Asia. Responsibilities include the ability to plan and manage at both the strategic and operational levels, analyzing market competitiveness, reviewing product pricing, oversee the hiring, training, development and compensation of the sales organization, and developing sales channel strategies. -------------------------------------------------------------------------------- Director Marketing Reports To: VP Marketing Salary: 100 to 120 + 20% bonus Education: 4 year degree with specialization in Marketing. Requirements: 5 years senior management experience in Medical Product Marketing and Sales of Surgical 5/5/2017 11 Equipment. A track record of success, defining, developing and launching new medical products and managing the marketing and sales process. Experience in managing Marketing Product Managers. Experience in Strategic Planning, forecasting and budgeting. Senior level management and leadership experience in marketing Medical Products, specifically surgical and diagnostic capital goods. Strong visionary, strategic, and tactical understanding of the Medical Product Market, with emphasis on creating product demand and generating revenues. Hands-on experience and demonstrated success, managing innovative products through their lifecycle including product positioning, launch, branding, thought-leader development etc. Strong technical project and product management skills. Solid track record and proven success defining, developing and promoting Medical Devices. Duties: The Director of Marketing is a key corporate executive responsible for all Company NY marketing activities, which include: Marketing strategy, product marketing, product management, marketing programs, marketing communications, and market research for existing worldwide markets. Identify new product opportunities in the company's product lines, and develop new product strategic plans which may become the blueprint for new product development, marketing and sales. Evaluate competitors and provide competitive differentiation. Design and manage compelling marketing communication strategies to increase customer base. Provide direction and leadership to sales management and field sales to implement strategy and tactics. Full responsibility for the Marketing budget. Help develop accurate Sales forecasts and an expense budget to support the forecast. Structure business milestones and develop a strategic roadmap. As Director of Marketing, you will interact with the executive managers of all company branches. You will be a key player in defining the company's vision, positioning, strategy, lifecycle, and product roadmaps. -----------------------------------------------------------Quality Engineer Location: Upstate New York Reports To: Director Engineering Salary: 65K Education: BS degree in Engineering. Requirements: 3 years exp., ASQ or CQE preferred. Duties: Prepares ISO compliant documentation and provides training support, participates in new product design reviews, champions corrective action process relative to internal and external 5/5/2017 12 product/customer complaints, designs /conducts experiments for root cause determination, generates vendor corrective actions and follow up, develops testing to assure compliance to all internal and customer regulatory specs and develops supplier quality improvement initiatives. -------------------------------------------------------------------------------Product Manager, Bioprocess Reports To: VP of Marketing Salary: 65K Education: Bachelors Degree, Engineering, life sciences with specialization in process or automation engineering. Requirements: Degree in Engineering, life sciences with specialization in process or automation engineering. Member ISPE. Demonstrated skills in MS Word, Excel, Outlook, Power Point, written and verbal communications. Effective customer interaction skills. Demonstrated ability to learn complex medical field. Duties: Overall product support, market development, sales support, customer support, product development and manufacturing that affect the profitable growth of Company flow meters and sensors to the bioprocess market. Work with outside consultant to develop plan including promotions, trade shows activities, educational programs, key customer presentations, webbased programs, seminars and other promotional vechicles. Work through Engineering Department to manage changes to existing products and development of new products to increase market penetration and share. Develop and maintain strong working relationship with key customers. Maintain and contribute completive files including product details on major competitors. If interested in any of these above go to my web site below and fill out . ***************************************************** Contact : Otis J. Archie, President, [email protected], PH: 949-340-2136, Toll: 866-620-3927, Web: www.advancedmr.net <http://www.advancedmr.net/> Sr. Biomedical Engineer Senior Mechanical Engineer 5/5/2017 13 Clinical Application Specialist Sr. Test Engineer Analog Design Engineer Quality Assurance Technician Dir/Sr. Electrical System Hardware Manager/Engineer Electrical Engineer Mechanical Engineer Software Engineer Quality Assurance Manager Manager, Hardware/Electrical Engineering Test Engineer Senior Staff Engineer (Mechanical Design Sr. Production Test Engineer _______________________. Dir/Sr. Electrical System Hardware Manager/Engineer Execute electrical design projects, manage schedules and report to the senior R&D executive. Perform analog, digital circuit design and system testing, write test plans, protocols and test summary reports. Develop system architecture, select electronic components, microprocessors for critical function of medical devices. Work closely with mechanical and software engineers to develop product & system requirements, hardware specifications, and system risk analyses. Lead product design reviews, project management, and other project team activities as required. Supervise fabrication of PCB assemblies at vendors and ensure release into production following the design control process. Provide sustaining engineering support to existing products and participate in improvement projects for increased reliability, weight, and cost reduction. Strong background in analog & digital design, and medical device system design. Embedded & control system design and implementation. Schematic capture with Orcad and PCB layout with PADS. Microprocessors: ST Micro and PIC Micro, or similar devices. System Architecture: Familiar with memory options, power supplies, electromagnetic 5/5/2017 14 interference, LCD and touch sensitive displays, and design for reliability. Sufficient knowledge of software to work with real time operating systems. Experience in managing the design and development of electronic systems, including microprocessor-based circuit design and complex system interface design. Experience in managing software development (C, C++), particularly for embedded systems. Analog Circuits: Experience with Signal Conditioning, Active Filters, Electrical Isolation. ____________________ Electrical Engineer Researches, develops, designs, and tests electrical components, equipment, and systems by performing the following duties. Design of electronic assemblies for ventilator and related equipment in a regulated product development environment. Design printed circuit assemblies. Perform the fabrication and assembly of prototype circuit assemblies. Write the qualification and other test protocols. Perform engineering and qualification testing. Perform failure analysis on ventilator electrical system. Bachelor's degree or higher degree in engineering or physical science. Knowledge of standard schematic drawing practices, and PCB design practices. Knowledge of lab electrical equipment (i.e. oscilloscope, logic, analyzer, etc....) and lab diagnostic techniques. _________________________ Mechanical Engineer Researches, plans, and designs mechanical parts and assemblies for ventilator and related equipment by performing the following duties. Design of mechanical parts and assemblies for ventilator and related equipment. Solid Works and AutoCAD experience is mandatory. Design of pneumatic components and assemblies. Perform the fabrication and assembly of prototype parts, assemblies, and complete units. Write the qualification and other test protocols. Perform engineering and qualification testing. Bachelor's degree or higher degree in engineering or physical science. Knowledge of standard mechanical drawing practices, CAD software; Solid Works and AutoCAD is mandatory. ________________________ Software Engineer Researches, designs, and develops computer software for microprocessor systems for ventilators and related equipment. Research, design, and develop computer software from inception of project to end of project. Write the qualifications and other test protocols. Perform engineering and qualification testing. Write specifications, provide appropriate materials for validation testing. Must be familiar with engineering equipment (i.e. scope, emulator, data acquisition). Manage a project from conceptual design to production release. Occasional travel may be required. Bachelor's degree or higher degree in software design, engineering, physical science, or mathematics _______________________________ 5/5/2017 15 Quality Assurance Manager Develops and maintains a system to assure that all products manufactured by the organization meets required specification and achieves superior quality and reliability levels. Assists the Director of Quality Assurance in all matters related to Quality, Compliance, Governmental and Operational activities. These would include the agencies of NIOSH, FDA, State DHS, ISO and Australian SAI Global. Ensure compliance with national and international standards and legislation. Identify and implement relevant quality-related training needs. Perform statistical analysis on processes and make recommendations for improvements as appropriate. Oversee, maintain and improve company ISO 9001: 2000 program. Troubleshoot and resolve product quality problems by researching problems, analyzing data and developing solution to problems. Bachelors in Engineering or Science Knowledge of regulatory requirement such as FDA. Experience in manufacturing and/or quality related field. Ability to effectively work with other department heads and upper management. _______________________________ Manager, Hardware/Electrical Engineering An ideal candidate in this role would have strong technical background in analog/digital electronics design, hands-on product development experience, and has successfully managed medical products through market adoption. Execute electrical design projects, manage schedules and report to the senior R&D executive. Perform analog, digital circuit design and system testing, write test plans, protocols and test summary reports. Develop system architecture, select electronic components, microprocessors for critical function of medical devices. Work closely with mechanical and software engineers to develop product & system requirements, hardware specifications, and system risk analyses. Lead product design reviews, project management, and other project team activities as required. Supervise fabrication of PCB assemblies at vendors and ensure release into production following the design control process. Provide sustaining engineering support to existing products and participate in improvement projects for increased reliability, weight, and cost reduction. Strong background in analog & digital design, and medical device system design. Embedded & control system design and implementation. Schematic capture with Orcad and PCB layout with PADS. Microprocessors: ST Micro and PIC Micro, or similar devices. System Architecture: Familiar with memory options, power supplies, electromagnetic interference, LCD and touch sensitive displays, and design for reliability. Sufficient knowledge of software to work with real time operating systems. Analog Circuits: Experience with Signal Conditioning, Active Filters, Electrical Isolation _____________________________ 5/5/2017 16 Test Engineer This position will be an integral part of the engineering research and development team. This individual will oversee and conduct laboratory evaluation of products to establish information that will be used in our new product development programs and marketing efforts. A successful candidate in this role will have the opportunity to progress into a design engineering role in Product Development. Interact with Product Development Engineers, Product Managers, Sales, and Marketing to understand key product performance factors for orthodontic products. May require periodic visits to doctors' offices for the purpose of gaining a better understanding of how orthodontic products are used in the field. Plan and perform materials and performance tests on orthodontic products. Develop testing protocols, interpret results and write reports on the outcome of the evaluation. Maintain appropriate documentation (records and lab notebooks) as required. Education/Experience: Entry level, with a Bachelor of Science Degree in Mechanical Engineering or Materials Science. Skills/Abilities (listed in order of priority): 1. Must be results oriented, a self-starter with good time management skills and a sense of urgency on completing projects. Able to prioritize and manage multiple tasks 2. Must possess the ability to accurately and precisely perform testing procedures and apply basic statistical analysis to the results. 3. Must possess good communication skills, verbal and written - must be capable of presenting essential data and results in a clear and concise manner to technical and non-technical personnel. 4. Good command of pertinent computer software applications - Microsoft Word, Microsoft Excel, and CAD (Computer Aided Design). _________________________ Senior Staff Engineer (Mechanical Design) Proposes conceptual product design solutions. Takes conceptual product designs through all phases of development to pilot release. Creates Solid Works drawings, performs tolerance analyses, specifies appropriate materials. Selects vendors and subcontractors. Develops product fabrication processes. Organizes and prepares formal design reviews. Prepares prototypes and performs bench and animal testing. Interacts with personnel from other company departments to refine product specifications. Aids in the FMEA. Interacts with clinicians for product feedback. Designs and prepares prototype tooling. Supports tasks necessary to release product into full production. May manage technical consultants, engineers and technicians. Bachelor's degree in Engineering field preferably Mechanical Engineering and a minimum of 10 years product development experience in the 5/5/2017 17 medical device field. __________________________ Sr. Production Test Engineer Develop electrical testing and troubleshooting procedures for hybrid and implantable defibrillator electronics. Document these procedures in accordance with the company's Quality System. Perform advanced troubleshooting of electrical test failures. Appropriately document all troubleshooting activities and disposition failures in accordance with the company's Quality System. Perform advanced troubleshooting of electrical test equipment issues. Properly document all maintenance and calibration activities in accordance with the company's Quality System. Develop and maintain database for logging and tracking electrical test results. Validate database to comply with the company's Quality System and external standards. Provide periodic reports on electrical test yields. Identify trends in failure modes and root causes. Initiate and lead projects to address these issues. Develop and execute protocols for validation of electrical test systems to comply with the company's Quality System and external standards. Qualifications : Bachelor of science degree in electrical engineering, and 3 years of manufacturing test experience in medical or other high-reliability environment, or equivalent combination of education and experience. Experience with both analog and digital circuit design. Strong knowledge of standard electronic troubleshooting processes. Familiarity with electronic equipment such as oscilloscopes, logic analyzers, DVM's, spectrum analyzers, and computerized test equipment. Ability to read and interpret circuit schematics and layout drawings for the purpose of understanding test system and device operation. Experience programming in C, Labview or equivalent. _____________________ Quality Assurance Technician Support manufacturing and quality assurance groups to ensure quality product and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Class III Medical Devices. Examine and use prints, schematics, work instructions and procedures .Responsible for the maintenance of the NCMR program. Responsible for ensuring SPC data is accurate and collected in a timely manner. Assist in the analysis and reporting of SPC data. Assist in more complex inspection and verification of materials and product and associated documentation. Assist and perform quality systems training to company employees. Assist in the establishment of accept/reject limits for product. Assist and perform disposition, analysis, and reporting of deviations and NCMRs. Assist and perform trending and reporting of NCMRs, internal and external yields, and supplier corrective action. Qualifications: Bachelors degree, or Associates degree with 2 years related experience (medical device experience 5/5/2017 18 preferred), or equivalent. ASQ Certified Quality Technician (preferred). Knowledge of quality control and quality standards, handbooks, and specification. Sound working knowledge of computer software [Microsoft Word, Microsoft Excel] (required) along with various statistical programs [Minitab, SPSS, WinSPC] (preferred). __________________________ Analog Design Engineer The Analog Design Engineer is responsible for assisting in the electrical design and development of an implantable defibrillator. Participate in design, development, and evaluation of low power, low level analog circuitry at the ASIC and board level including amplifiers and switch-mode power supplies. Comply with all design related standards as developed by external regulatory groups. Comply with department and corporate quality initiatives. Qualifications: BS in Electrical Engineering is required. An advanced degree is highly desired. Minimum of 1-2 years of experience in analog design; low-power design or high voltage circuit design desirable. Strong educational background in analog circuits is required. Medical device or related biomedical experience is highly desired . ASIC development experience is a plus. Familiarity with Orcad, PSPICE, and Mathcad a plus. ______________________________ Sr. Test Engineer Assist in the design, development and evaluation of new circuits and systems. Design, layout, and build prototype circuits and test fixtures. Troubleshoot and repair circuits and fixtures. Perform tests on circuits and designs using OTS or internally developed test equipment. Program, on a limited basis, circuits and test fixtures. Document all activities from schematic capture to test results. Qualifications: BSEE is a must. 5 years, minimum, experience in prototyping and evaluation of digital and analog electronic circuits in an R & D or Engineering Lab environment. 1 year, minimum, experience in programming microprocessor or FPGA based new products or test fixtures, desirable. Prior use of electronic CAD and/or schematic capture tools are preferred Expertise in the use of electronic equipment such as oscilloscopes, logic analyzers, DVM's, spectrum analyzers, etc. LabView experience is a must. ________________________________ Clinical Application Specialist The Clinical Application Specialist provides Clinical Sales Support to their designated regional territory. Will be responsible to perform in-service and train clinicians in the hospital and home care arena about ventilators. The Clinical Application Specialist is responsible to provide Clinical support pre-purchase of product and on-going clinical support after the product is purchased. Train Dealers and Distributors on the product. Explain product 5/5/2017 19 features, use and advantages to customers' pre and post sale. Assess training needs of customers and deliver product training as needed or requested by the Sales Manager. Stay current in the knowledge of respiratory care/mechanical ventilation practices relative to company products. Travel is required. Must reside in California. 3 to 5 years related experience and/or training; or equivalent combination of education and experience. Respiratory Therapy and critical care background is required. Must have excellent knowledge of clinical procedures and medical terminology. Must have good communication skills. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. _________________________________________________ Senior Mechanical Engineer Senior R&D Mechanical Engineer with a proven track record of designing and developing a variety of medical devices or scientific instrumentation from concept through prototype and into production. The candidate shall be experienced in effectively managing interdisciplinary projects while working in an ISO 13485/FDA regulated environment, and be responsible for key product design and development work. The candidate shall have broad experience and demonstrated creativity and effectiveness in implementing materials and fabrication processes during the development of commercial medical devices, including injection molding, machining, welding, casting, and bonding of plastics, elastomers, metals, coating and plating, and other high and low volume manufacturing techniques. Also required is experience in developing protocols, measurements and tests, and design of experiments for development of medical devices and electromechanical devices. The candidate shall have experience in the integration of electronics, software, industrial design, and design for manufacturability of medical devices. Demonstrable proficiency with Solid Works is required (Pro/E expertise may be substituted). Experience in performing engineering analysis and modeling such as stress-strain, heat transfer, fluid flow, and machine dynamics is desired. Must have a BS/MS in Mechanical Engineering and minimum of four years experience in the medical device industry and 8-10 years experience in electro-mechanical packaging design, analysis and documentation. ______________________________________________ Sr. Biomedical Engineer Designs, executes and interprets experiments that contribute to product strategies. Guides a cross-functional engineering team to complete biomedical engineering tasks like developing proof-of-concept and prototype stage medical devices. Plans and conducts applied research in the engineering lab and on large animal models of cardiac arrest and myocardial infarction with in collaboration with team members. Makes detailed observations, analyzes data and interprets results. Prepares technical 5/5/2017 20 reports, summaries, protocols and quantitative analyses. Provides regular status and research updates to multiple stakeholders. Investigates, creates and develops new technologies for product advancement. SKILLS: The requirements listed below are representative of the knowledge, skill, and/or ability required: in-depth knowledge of physiology, biomedical engineering, sensors and general engineering is essential; strong background in medical devices or instrumentation; very strong communication and interpersonal skills; knowledge of cardiovascular physiology, blood-contacting biomaterials, and in vivo experimentation; exposure to product development; ability to work in a cross-functional, matrixed work environment with multiple stakeholders; ability to travel domestically and internationally; exposure to clinical studies is optional. Master's degree or doctorate in biomedical or electrical engineering or equivalent, plus 1-5 years related experience or equivalent combination of education and experience. Experience with statistical analysis, Excel, and MATLAB or other numerical computation package ***************************************************** Qualified candidates please reply to: Gil Paz [email protected] tel: 925-242-1010 x 102 Below you will find our current update on positions we are working on in medical device here in the SF Bay area as well as a few positions in Southern California. You are welcome to pass this along if you know anyone that might be interested in taking a look. If you have any questions, please feel free to get in touch anytime. Most Urgent Positions: CFO Director of Clinical Science (pre-clinical) Worldwide Director of Marketing Sr. / Principal R&D Engineer (3 roles total) R&D, MANUFACTURING & OPERATIONS ROLES CFO Bachelor’s degree in business or accounting, MBA or CPA preferred 10+ years accounting experience, including controllership and CFO responsibilities Strong GAAP knowledge Prior experience in SEC reporting and Sarbanes-Oxley compliance Sr. R&D Engineer or Principal Engineer (Mechanical Design) BS/MS Mechanical Engineering 5/5/2017 21 2-5 years R&D medical device experience (10 years preferred for Principal) ProE experience strongly preferred, SolidWorks acceptable Full life cycle product development experience – concept to launch R&D Engineer (Mechanical Design – 2 roles) BS/MS Mechanical Engineering 1-3 plus years R&D medical device experience ProE experience strongly preferred, SolidWorks acceptable Polymer knowledge helpful Robotics Software Engineering Manager PhD in Computer Science or Electrical Engineering 10+ yrs software development in an embedded environment, including developing products with C/C++, Borland C, and Open WatCom C, and GNU C Strong software architecture development and algorithm development background Motion and machine control experience preferred Robotics Software Engineer Masters degree preferred in Mechanical Engineering or equivalent software design experience 2+ yrs software development in an embedded environment, including developing products with C/C++, Borland C, and Open WatCom C, and GNU C Strong algorithm development background Experience with source code control Field Service Engineer § BS degree § 5 – 7 yrs hands-on field service experience § High level understanding of system electronics, MSDOS and Linux § Excellent customer relations and organizational skills required Senior Software Systems Engineer BS/MS in Software Engineering, Electronics Engineering, Computer Science or related discipline 5-8 years of experience in Windows desktop and embedded development Experience in applications using .NET Framework and .NET Compact Framework using C++,C# Experience in Windows CE kernel configuration and build using C and C++ Package Engineering Manager BS or MS degree in Engineering 6+ years in related field and 2 years of management experience Experience in medical and surgical devices, and implantable biomaterials desirable Solidworks experience preferred Senior Tooling Engineer BS degree in Engineering, Mechanical preferred 4-7 years in related field, or 3-5 years with an MS 2 years work experience with Equipment, Fixture and Tool design 5/5/2017 22 Good knowledge of Solidworks Sr. Manufacturing Test Engineer BS in Electrical Engineering, Computer Science or related field 7+ years experience in manufacturing test engineering within a NPI environment 6 Sigma Black Belt and Demand Flow Technology a plus Manufacturing Engineer BS degree in mechanical, electrical, chemical, materials or industrial engineering 3+ years experience in manufacturing environment ProE competency is desirable SALES, MARKETING & BUSINESS DEVELOPMENT Worldwide Director of Marketing BS degree in business or related field. MBA desired Experience with lifestyle medical products and female oriented products/services with consumer promotion is a big plus Experience in leading strategic and tactical planning Clinical manuscript management experience is a plus Regional Sales Director – Central and West Coast (2 positions) College degree required with MBA desired 3+ year’s successful management experience in aesthetics Experience in capital equipment sales, preferably in the aesthetics market Excellent verbal and written communication and coaching skills Regional Sales Director – Canada College degree required with MBA desired 3+ year’s successful management experience in aesthetics Experience in capital equipment sales, preferably in the aesthetics market Excellent verbal and written communication and coaching skills Marketing Manager (So. Cal) Bachelor’s degree in business or marketing (MBA preferred) 3-7 years of product management experience Upstream & downstream experience required Endovascular medical device experience preferred Strength in branding and positioning – strong commercialization experience Product Manager (So. Cal) BA/BS degree, MBA preferred 2+ years of Product Management experience medical device experience Sales Representative – Canada (3 positions) College degree required 3+ year’s successful medical device sales experience in aesthetics a plus Experience in capital equipment sales with disposable component Excellent verbal and written communication and coaching skills Sr. Product Manager BA/BS (MBA a plus) 5/5/2017 23 5-7 yrs of medical device and marketing experience Product launch experience Travel required Marketing Specialist BA/BS 3+ yrs of medical device and marketing experience 2+ yrs advertising, art communications or PR experience Use of MS Office, Desktop Publishing, Adobe CS, Photoshop Illustrator Travel 20% REGULATORY, QUALITY & CLINICAL AFFAIRS VP of QA/RA (So. Cal) BA/BS/MS degree in quality science, engineering or related field 15+ years experience in medical device Currently operating at a VP level Director of Clinical Science (pre-clinical) BS or MS in Life Sciences or Engineering is required 8-10 years of experience conducting pre-clinical studies in medical device or pharmaceutical is required Familiarity with preparation and submission of FDA IND and/or IDE applications is required Drug eluting stent experience preferred Clinical Applications Specialist (East Coast) BS, RN or technical experience preferred 2+ years medical device field training, sales and/or marketing Experience and working knowledge of electrophysiology, interventional cardiology, and cardiac surgery Experience with catheter or guidewire based technology a strong plus Travel required ***************************************************** ***************************************************** Jobs Listed From Period Sept. 28 through Oct. 3, 2008 ***************************************************** Scott Bailey, Senior Partner Ocean Medical, Inc. [email protected] Tel (904) 237 2407 Fax (904) 757 7200 Subject: Clinical Project Manager Positions Available We are currently searching for (3) Clinical Project Managers to manage class III trials in cardiology, neurology, and orthopaedic areas, for a CRO company based in Raleigh, NC. 5/5/2017 24 If you would like more details on these positions, please call or email me. Please feel free to pass this email along to others. Thanks! ***************************************************** The latest Employment Newsletter is available at the C.A.C.O-CA web site. There are 12 positions listed. To obtain the most current newsletter or old newsletters, please visit www.caco-ca.org - then click on the Employment Service link: http://www.caco-ca.org/aspx/emServices.aspx. Employer Position Amgen Sr Research Associate, PKDM Amgen Scientist-DMPK Requisition: NB50308977 Through Recruiter Field Service Engineer - direct hire Through Recruiter Polymer Chemist Through Recruiter Medicinal Chemistry Scientist I Through Recruiter Process Chemistry, Scientist I Scientist II/III, Crytallography Through Recruiter Scientist , Quality Control Through Recruiter QC Chemist Through Recruiter Research Associate, Analytical Method Development Through Recruiter Pharmaceutical Scientist Through Recruiter QC Supervisor ***************************************************** Dawn Mischler, Senior Recruiter If you know of anyone who would like more information please have them contact my at [email protected]. or 1-866-706-8024 x279. I want to let you know that I am actively sourcing individuals who are interested in a Director of Surgeon Education in San Diego. Looking for someone who has Bachelor's degree in Business and three to five years experience selling with a spine and/or orthopedics company. Summary: Works with the Director of Clinical Resources to deliver an effective surgeon training program that optimizes the surgical efficiency, procedural reproducibility, and patient outcomes by systematically teaching MAS procedural best practices. Drives rapid adoption of technology and procedures post-MVP to generate revenue and provide a return on investment. ***************************************************** Scott Bailey, Senior Partner Ocean Medical, Inc. [email protected] Tel (904) 237 2407 5/5/2017 25 Fax (904) 757 7200 Subject: Director Clinical Research Position Available We are currently searching for a Director Clinical Research to strategically direct, manage, and lead a team in the analysis, interpretation, and reporting of clinical trial data in preparation for a PMA submission. This professional will accept this newly created position, and join a team of repeatedly successful, financially strong, talented, medical device professionals in launching "the most exciting interventional cardiology product since the stent", located in the San Francisco Bay area, CA. If you would like more details on this position, please call or email me. Please feel free to pass this email along to others. Thanks! ***************************************************** Marilyn Williams, CSAM Senior Account Manager The Compass Network 9455 Ridgehaven Court, Suite 100 San Diego, CA 92123 Office: 858-565-6600 x329 Fax: 858-565-4937 [email protected] We are searching for a Product Manager who has experience with medical devices and can work independently. This PM will report to the Director of Marketing who travels frequently. The opportunity is in the Fremont area (Bay Area.) My client is a cardiac device company that focuses on cardiac arrhythmias. It's an opportunity to make a significant impact on the growth and direction of the company. ***************************************************** Visit www.keyrecruit.com to view other openings. Andrew Youngelson Key Recruit Inc. www.keyrecruit.com Manager, Clinical Operations Date Posted: 9/27/2008 Job Id: 1648 5/5/2017 26 Company: We are a leading global clinical research organization (CRO). We have proven proficiency in supporting worldwide clinical trials for medical device, pharmaceutical and biotechnology companies. We have an influential focus in the areas of Cardiovascular Diseases, Oncology and Medical Devices. We are devoted to providing clients with crucial thinking, customer service and quality deliverables. We are committed to making sure that each clinical trial is performed to the highest possible standards. Location: Massachusetts Reports To: Director, Clinical Operations Salary: $95-$110K Education: Bachelor's degree Requirements: Minimum 3 years direct industry experience including 1 year of project and / or staff management experience. Must have a strong understanding of Medical Terminology, Physiology, and Pathophysiology. Must have strong working knowledge of Good Clinical Practices. Must have strong management skills. Must have: strong organizational and time management skills; the ability to multi-task; the ability to work effectively in a fast-paced environment; strong written, verbal communication and diplomacy skills. Preferred Qualifications: MS; 2 years experience in project and/or staff management; 3+ years experience in a CRO; very strong management skills. Duties: The Manager, Clinical Operations manages and coordinates aspects of Clinical Operations activities including successful execution of projects, resourcing and personnel activities to assure the successful completion of projects and achievement of departmental goals; promote SOP compliance. Serves as a primary point of contact for CRA staff, clinical project managers, executive staff and clients. Coordinate all aspects of Clinical Operations including, but not limited to, maintenance and revision of standard processes and procedures; coordination of project timelines, deliverables and schedules; department budget management; communication with client, clinical project managers and CRAs to promote project schedule adherence; staff management. Review staff/department billable percentages. Assist the Director, Clinical Operations with the proposal/budget development process. Participate in internal, client/sponsor, sales, scientific and other presentations as required. Periodically review and revise: - appropriate standard operating procedures; - divisional procedures and policies. Establish standard guidelines and timelines for divisional responsibilities and modify, as needed, for each project. Assist in development of case report forms and other relevant project documents and tools. Assist in the design and implementation of data collection forms and data collection strategies. Assist business development with presentations, sales related brochures, proposals, identification of prospective clients, etc. Manage and assist CRA activities with project team members to ensure 5/5/2017 27 efficient clinical monitoring and effective project completion. Work closely with clinical project managers to promote operations efficiency, teamwork and high morale. Manage personnel activities and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, make hiring recommendations, lead disciplinary actions, and delivers performance reviews). Additional Duties and Responsibilities: Provides clinical project coverage for CPMs and CRAs May assist in the development, implementation and assess the training program for Clinical Research Associates in compliance with GCP and industry standards. As always thanks for passing on! ***************************************************** Artemis Health Inc., located at Menlo Park, CA, has multiple job positions open. See the job description below R&D Scientist or Systems Engineer – Artemis Health Artemis Health is dedicated to the development of innovative products and services that provide women, their families, and physicians with accurate and timely information regarding maternal and fetal well-being. Working in collaboration with leading research and clinical institutions, and funded by venture capital, we have developed proprietary technologies that we believe will provide women with a simple, non-invasive, and accurate alternative to testing methods available today. With a single blood draw early in pregnancy, our test will provide valuable information without risk to the mother or her fetus. Artemis Health is currently seeking to fill the position of R&D Scientist or Systems Engineer. This position will fill an important technical role in the continual development of our proprietary technology. Artemis Health offers a stimulating environment in a dynamic and growing organization. The position provides professional growth opportunities, a competitive salary and benefits package including participation in the companies stock ownership plan. Responsibilities · Conceive of and produce mechanical, optical and/or electrical fixtures needed in the research and development of our cell enrichment system. · Act as in-house microscopy expert, maintaining existing fluorescent microscopes, upgrading when necessary, and training users when needed. · Maintain and upgrade control software (written in C) that runs on our prototypes. · Work with a diverse interdisciplinary team to perform experiments to test, troubleshoot 5/5/2017 28 and validate our systems. · Analyze data and provide technical reports that document system performance and recommend next steps. · Interact with engineers to design and build instruments and disposables. · Undertake general scientific and engineering tasks as a team member Qualifications · M.S. or Ph.D. in physics, bioengineering, chemical engineering or other related discipline. · Fluorescent microscopy experience. · Instrument control using Labview or C. · Ability to interact with a diverse interdisciplinary team. · Excellent interpersonal and communication skills. · Ability to work independently. Desired Qualifications · Experience with biological samples and wet laboratory. · Imaging processing experience. · Microfluidics experience. · Matlab or R experience. · Database maintenance experience. Senior Mechanical Engineer – Artemis Health Artemis Health is dedicated to the development of innovative products and services that provide women, their families, and physicians with accurate and timely information regarding maternal and fetal well-being. Working in collaboration with leading research and clinical institutions, and funded by venture capital, we have developed proprietary technologies that we believe will provide women with a simple, non-invasive, and accurate alternative to testing methods available today. With a single blood draw early in pregnancy, our test will provide valuable information without risk to the mother or her fetus. Artemis Health is currently seeking to fill the position of Senior Mechanical Engineer with experience in Life Science Instrumentation Research & Development. This position will fill an important technical role in the continual development of our proprietary technology. Artemis Health offers a stimulating environment in a dynamic and growing organization. The position provides professional growth opportunities, a competitive salary and benefits package including participation in the companies stock ownership plan. Responsibilities · Design and develop proprietary Electro-mechanical Instrumentation and disposables 5/5/2017 29 for an in-vitro diagnostic assay · Work with a diverse interdisciplinary team to perform experiments to test and validate the instrumentation · Analyze data and provide technical reports that document system performance, design history and recommend next steps · Manage vendor relationships and define manufacturing specifications · Manage projects related to instrument & disposable development and validation · Undertake general engineering tasks as a team member Qualifications · M.S. in Mechanical Engineering or related discipline · 5+ years industry experience developing automated laboratory equipment. · 5+ years experience with SolidWorks or similar CAD software (FEA a plus) · Ability to interact with a diverse interdisciplinary team · Excellent interpersonal and communication skills · Ability to work independently · Excellent written & verbal communication skills Desired Qualifications · Industry experience in the design, development and validation of microfluidic systems for in-vitro diagnostics · Experience with microfabrication or injection molding · Project management experience · Developing in a regulated environment (e.g. ISO9001, ISO13485, 21CFR820) Senior Mechanical Engineer - Disposables – Artemis Health Artemis Health is dedicated to the development of innovative products and services that provide women, their families, and physicians with accurate and timely information regarding maternal and fetal well-being. Working in collaboration with leading research and clinical institutions, and funded by venture capital, we have developed proprietary technologies that we believe will provide women with a simple, non-invasive, and accurate alternative to testing methods available today. With a single blood draw early in pregnancy, our test will provide valuable information without risk to the mother or her fetus. Artemis Health is currently seeking to fill the position of Senior Mechanical Engineer with experience in Life Science Instrumentation & Disposable Research & Development. This position will fill an important technical role in the continual development of our proprietary technology. Artemis Health offers a stimulating environment in a dynamic and growing organization. The position provides professional growth opportunities, a competitive salary and benefits 5/5/2017 30 package including participation in the companies stock ownership plan. Responsibilities · Design and develop proprietary disposables for an in-vitro diagnostic assay · Work with a diverse interdisciplinary team to perform experiments to test and validate the disposable · Analyze data and provide technical reports that document system performance, design history and recommend next steps · Manage vendor relationships and define manufacturing specifications · Manage projects related to disposable development and validation · Undertake general engineering tasks as a team member Qualifications · M.S. in Mechanical Engineering or related discipline · 5+ years industry experience developing high volume plastic disposable products, preferably for use with human blood. · Experience with injection molding · 5+ years experience with SolidWorks or similar CAD software (FEA a plus) · Ability to interact with a diverse interdisciplinary team · Excellent interpersonal and communication skills · Ability to work independently · Excellent written & verbal communication skills Desired Qualifications · Industry experience in the design, development and validation of microfluidic systems for in-vitro diagnostics · Project management experience · Developing in a regulated environment (e.g. ISO9001, ISO13485, 21CFR820) ***************************************************** 5/5/2017 31