Principal Research and Development Engineer
My client, a well established start-up is hiring a Principal R&D Engineer to join their team.
This role provides key support to the R&D function in developing products, processes, materials requirements and equipment in order to achieve design brief. Ensure the company’s design control responsibilities are fulfilled, specifically development and design verification phases and related sustaining engineering activities
Contact me to hear more details.
Skills, Qualifications & Experience
- Mechanical Engineering degree or higher.
- Minimum 10 years’ experience in medical device design/development or similar role in a medical device company.
- Strong technical aptitude with a detailed understanding of fundamental engineering principals.
- Fundamental knowledge of materials (Nitinol, stainless steel, polymers) and processes used in medical devices.
- Fundamental knowledge of statistical analysis.
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Detailed knowledge (track record) of FDA requirements/submission (e.g. 510K approach) including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
- Strong knowledge of applicable (ISO) standards.
Working knowledge of the Medical Device Directive (93/42/EEC)
Excellent Salary & Benefits.
For a confidential discussion and more information on this role, please contact Nicola Walsh.