Job description
The Development & Design Transfer Engineer reports to the CTO / Director D&D and is responsible for the design & development of medical devices and for establishing, maintaining & optimizing external suppliers and manufacturers collaboration. In doing so, the individual will reference state of the art technology and development best practices and provide support on risk management and usability engineering activities. The individual will also represent manufacturing engineering as a project core team member responsible for design transfer to production, supporting process validations and efficiency optimization of processes considering business planning.
Salary: <120,000 CHF + Benefits
Work Style: Hybrid
Responsibilities:
Develop product from concept to validation phase considering regulatory and quality parameters according to the ISO 13485 standard, specifically risk assessment and usability requirements
Conduct and document verification/validation/engineering testing
Create specifications and support production by monitoring manufacturing activities
Participate in the selection and qualification of new suppliers, and work closely with suppliers, purchasing and development to ensure design requirements are adequately defined and met
Qualifications and Experience:
Bachelor or Master’s degree in Mechanical or Electrical Engineering, Material Science or related Engineering disciplines
Minimum 5-years development/engineering experience in medical device industry, preferably in implantable and/or active medical devices and system engineering of medical devices
Expertise in development and documentation according to ISO 13485 and FDA requirements (e.g.: 510(k) pathway, etc.)
Understanding of former MDD 93/42 EEC and MDR 2017/745 is a plus
Experience in risk management of medical devices according to ISO 14971
Experienced in application of usability engineering according to IEC 62366
Track record in management of design transfer and management of external suppliers
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.