Download job specification - Irish Medtech Association

JobSpec-109 Rev. 0
VistaMed Limited,
Carrick-on-Shannon,
Co. Leitrim, Ireland.
Tel. +353 (0)71 9638833.
Fax. +353 (0)71 9671345
Web. www.vistamed.net
JOB SPECIFICATION
Job Title/ Position:
Senior R+D Engineer
Required Qualifications/Experience/Skills:
 Third level Qualification in Engineering or Science, preferably in Mechanical
or Medical, Minimum Bachelor’s Degree in a Science / Technology /
Engineering related discipline (Mechanical, Manufacturing, Automation or
equivalent);

Ideally Design capability with CAD systems (Solid Edge)

Minimum 6 years. previous experience in a Medical Devices Environment with
knowledge of medical device products and associated manufacturing
processes, in particular with extrusion based catheter assemblies.

Strong interpersonal and communications skills

Motivated and Self-starting

Ability to manage multiple tasks and adapt to changing, fast paced
environment.

High level computer skills including Internet Explorer, Microsoft Excel and
others.
Duties/Accountabilities (incl. Deputation):
This involves but is not limited to:
Business Acquisition

Generation of product & tooling drawings to support Quotations, Prototyping
and Process Development.

Product and process concept generation, presentation, prototyping and
development.

Support on a technical level to the Sales and Marketing Team.

Creating assembly & project quotations and communicate effectively with
customers.
Form-0068 Rev.4
JobSpec-109 Rev. 0

Dealing with customer enquiries and be able to communicate clearly both
written and oral.
Form-0068 Rev.4
JobSpec-109 Rev. 0
Product and Process Development

Development of Products, Processes and Equipment, including product and
material specifications, material sourcing, equipment and tooling specifications
and sourcing, process development and testing, to develop new products for
customers or the Company from concept to design freeze.

Project manage all developments to ensure that all commitments are achieved
including functional prototypes, delivery dates, design iteration samples, test
protocols and reports, project costs and other project deliverables are
achieved.

Ensure full compliance with all Quality, Regulatory, Health and Safety and other
relevant legislation. This will include the completion of Design History Files,
Design Inputs, Outputs, Design Reviews, Log books, etc as necessary. Ensure
full traceability of Design Development and control of changes.

Ensure full and effective transfer of new products after Design Freeze to
manufacturing areas ensuring that the product and processes are fully
developed to allow product/process validation to begin. Provide comprehensive
training to production, quality and technical staff to ensure a smooth production
start including validations and records. Note that this stage is to be handles
through the official change control (ECR/ECO) procedures.

Constantly review the development processes to ensure they are effective and
compliant with the goal to achieve the optimum development cycles at
minimum cost. Ensure Lean GROWTTH principles are followed especially 3P,
5S, DMAIC and 6 sigma.

Provide effective internal and external reporting. Ensure Tax credit data and
reports are maintained and compiled ongoing and are available at the end of
each year.

Ensure the development centre is fully equipped and maintained in excellent
order as this centre will provide a “selling point” for new and existing customers.

Develop and maintain a positive and friendly atmosphere in the centre.
Motivate the development team and ensure effective use of resources.

Train and develop junior engineers and other technical staff. Assign tasks and
provide support and assistance to the development team.

Provide assistance and support to other departments including Production,
Quality and Technical as required. This could include major issues with new
products/processes developed, resource balancing and major priorities.
Participate in CAPA, Audit, Validation, MRB/NCMR activities if required.
Form-0068 Rev.4