Senior Mechanical Engineer
HybridMechelen, Flanders, Belgium
Job Summary
Lead mechanical development for active hearing implants and surgical tools, driving the full lifecycle from concept and CAD prototyping to verification, validation, and industrialization. Define solutions for complex electro-mechanical challenges, conduct risk analysis and DFMEAs, and collaborate with surgeons and suppliers to optimize designs. Execute rigorous safety testing protocols using cadaver material, manage technical work packages within scope and budget, and mentor junior engineers. Ensure compliance with ISO 13485 and MDR/FDA standards while generating patent disclosures for novel concepts.
Required Qualifications
- Master's degree in (Electro)mechanical, Mechatronic, or Biomedical Engineering (or equivalent by experience)
- Minimum 10 years of experience in design and product development using 3D CAD
- Minimum 5 years of hands-on experience in prototyping and verification of mechanical designs
- Fluent in English (written and oral)
- Proficient in 2D and 3D CAD modeling
- Proficient in mechanical drawings
- Proficient in tolerancing
- Proficient in V&V principles
- Strong technical writing skills
- Strong interpersonal communication skills
- Organizational skills
- Ability to lead and deliver project goals through others
- Pragmatic mindset with the ability to solve complex, non-standard engineering problems
Desired Qualifications
- Proven experience with (implanteable) medical devices
- Multidisciplinary technical background (e.g., electronics, acoustics, process engineering)
- Knowledge of additional EMEA languages
- Experience with PTC Creo
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