R&D Engineer
Your main role
1. Lead the design and development of the TRIFLO Heart Valve prosthesis and its surgical accessories, and actively support the industrialization at external partners.
2. Lead design control and risk management documentation (RTM, FMEAs, …) along product development cycle.
3. Create and update product assembly and detailed drawings using CAD software.
4. Lead and support process validation activities, including IQ, OQ, and PQ, to ensure all processes meet regulatory requirements.
5. Develop test methods and tooling.
6. Document and support Engineering Change Requests (ECR), including impact on suppliers.
7. Update design documentation (specifications, drawings, Bill of Material (BOM), Manufacturing Flowchart (MFC)).
8. Complete Non-conformities (NC), Corrective/Preventive Actions (CAPA) linked to design activities and lead technical investigations when required.
Your profile
1. Bachelor's or Master’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related technical field.
2. Min. 4 years’ experience as an engineer in the medical devices sector, ideally in the cardiovascular industry.
3. Technical knowledge in mechanics, surface treatment, and material science.
4. CAD proficiency, specifically in SolidWorks software.
5. Proven experience with product development and regulatory submission.
6. Knowledge of the medical device industry regulations (FDA, MDR, ISO 13485 and ISO 14971).
7. Rigor, attention to details, dedication, self-driven, and sense of responsibility.
8. Ability and willingness to work in start-up environment.
9. Excellent communication skills in English (C1) and French (German is a plus).
Additional information
1. Starting date: November 2024
2. Location: Lausanne – Biopôle
3. Activity rate: 100%
Your primary contact for this position is: c.nemoz@novostia.com
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