Senior Medical Device Design Engineer — Lead & Scale

ROM Utrecht Region; Utrecht; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

ViCentra B.V. is seeking a senior design engineer to lead the development of medical devices from concept to production. You will manage multiple projects, define requirements, and ensure compliance with GMP and regulatory standards.

The role emphasizes hands-on design, prototype testing, and collaboration with management, peers, and suppliers to bring ambitious devices to market. Prior start-up or scale-up experience is a bonus.

Qualifications

• Own multiple design projects from first concept through to production, driving each one to launch on time and on budget.
• Prototype, test, and refine across the full product development life cycle, learning fast and iterating with intent.
• Invent and optimise new manufacturing methods and techniques that bring ambitious designs to life at scale.
• Set the requirements and specifications that ground your ideas in reality, and build the mechanical testing, derisking plans, and protocols that prove them out.
• Run GMP process validations and complete the quality system documentation that lets new processes go live with confidence.
• Guide, mentor, and inspire colleagues, sharing your craft to lift the whole design team.
• Partner closely with management, peers, and vendors; articulating your thinking clearly to specialists and non-specialists alike.
• Champion compliance with every approved quality process and regulatory, legal, and company standard.
• 7+ Years designing and developing medical devices — or products in a similarly regulated industry, with a proven track record of carrying projects end to end.
• Deep, hands-on knowledge of designing and manufacturing small parts (fine mechanical engineering).
• Injection moulding design and processing experience, plus time in a start-up or scale-up, are both a real bonus.

Skills

Design engineering

Medical devices

Project management

Technical writing

Problem solving

Manufacturing methods

Quality assurance

Injection moulding design

Tools

SolidWorks

Job description

ViCentra B.V. is seeking a senior design engineer to lead the development of medical devices from concept to production. You will manage multiple projects, define requirements, and ensure compliance with GMP and regulatory standards.

The role emphasizes hands-on design, prototype testing, and collaboration with management, peers, and suppliers to bring ambitious devices to market. Prior start-up or scale-up experience is a bonus.