Scientist / Device Engineer | Scientist / Device Engineer | M/W/D - Referenz 001130
consult16 GmbH
Job Summary
This role involves joining an internationally successful pharmaceutical company in the Mainz area to lead the design verification of medical devices and combination products. You will be responsible for planning, executing, and coordinating design verification studies while ensuring strict compliance with regulatory requirements. Your day-to-day will involve representing the evaluation engineering department within the device development team, managing work packages for design verification, and creating submission-relevant plans and reports. You will also collaborate closely with cross-functional teams including Design Engineering, Quality, Risk Management, and Usability Engineering. This position is particularly attractive for professionals seeking a hybrid work model within a highly regulated, innovative environment. It offers the chance to influence the development cycle of life-saving medical products and contribute to the evolution of regulatory standards within a leading global organization.
Required Skills
Education
Completed academic degree in a Life Sciences discipline (e.g., Biology, Chemistry, Biotechnology, or Medical Engineering).
Experience
- Several years of professional experience in a Life Sciences discipline
- Professional experience with Design Control processes for combination products
- Experience in a highly regulated environment (Pharmaceutical/Medical Device)
- Proven experience in planning, executing, and documenting design verifications for combination products
Languages
Additional
- The position is initially limited to 12 months. Hybrid work model available (partial remote) but requires on-site presence in the Mainz area for training and key appointments. No travel or accommodation costs are reimbursed.
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