Senior Mechanical Engineer – Medical Devices

About the role

We are seeking an experienced Senior Mechanical Engineer to lead the development of active hearing implant technologies, surgical instruments, and packaging solutions. You will work in a multidisciplinary R&D environment, translating clinical, manufacturing, and regulatory needs into robust, manufacturable designs that meet the highest quality standards.

Key responsibilities

• Lead mechanical design of complex electro‑mechanical components for hearing implant systems.
• Define engineering requirements based on user, clinical, and regulatory inputs.
• Generate and evaluate innovative concepts, conduct design reviews, risk analyses, and DFMEA activities.
• Create and maintain high‑quality 3D CAD models, detailed drawings, and design documentation.
• Coordinate prototyping, supplier activities, and rapid product development.
• Develop and execute verification and validation strategies, including test method design, fixture development, and testing on temporal bone and cadaver models.
• Prepare test plans, protocols, reports, and technical documentation.
• Support manufacturing teams with prototype builds, inspection planning, and design for manufacturability.
• Contribute to intellectual property through patent disclosures.

Required profile

• Senior‑level experience in mechanical design of implantable medical devices.
• Proven ability to lead multidisciplinary projects from concept to first‑in‑human studies.
• Strong understanding of quality management systems, regulatory requirements, and risk management processes.
• Demonstrated agility in adapting to evolving technical challenges and business priorities.

Required skills

• 3D CAD modeling and detailed drawing creation.
• Design Failure Mode and Effects Analysis (DFMEA) and risk analysis.
• Mechanical simulation and problem‑solving workshops.
• Prototype coordination and supplier management.
• Verification & Validation test method development.
• Testing on temporal bone and cadaver models.
• Technical documentation and test reporting.
• Patent disclosure and intellectual property contribution.