Head of Hardware Engineering (Medical Devices) f/m
We are looking for a Head of Hardware Engineering to lead our hardware team and take ownership of the journey from a working prototype to a scalable, regulatory-compliant medical device.
What you'll do
- Lead, mentor and grow the Hardware Engineering team.
- Drive design transfer and New Product Introduction (NPI) from prototype to volume manufacturing.
- Manage relationships with contract manufacturers (CMOs) and key suppliers.
- Oversee DFM, DFT, pilot builds, process validation (IQ/OQ/PQ) and production ramp-up.
- Own the hardware contribution to the Quality Management System (QMS), technical documentation and regulatory compliance (CE-IVDR/FDA).
- Manage the hardware roadmap, milestones, engineering changes and project risks.
What we're looking for
- Proven experience taking a regulated electronic or medical device from prototype through design transfer to manufacturing.
- Strong knowledge of ISO 13485, ISO 14971, IEC 62304 and Design Controls.
- Experience leading and developing engineering teams.
- Hands-on experience with NPI, Design Transfer, DFM/DFT and contract manufacturing.
- Good understanding of IEC 61010, IEC 60601 and EMC/EMI compliance testing.
- Fluent English and Polish.
Nice to have: experience with IVD, point-of-care devices or biosensors, familiarity with CE-IVDR and/or FDA regulations, and experience in a startup or scale-up environment.
What we offer
- A key leadership role in developing an innovative medical device.
- The opportunity to shape both technology and engineering execution.
- Competitive compensation, equity participation, and flexible employment (Permanent or B2B).
- Hybrid work based in our R&D hub in Gdynia, with regular collaboration across international teams.