Head of Hardware Engineering Medical Devices f/m, GDYNIA

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.

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 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.

,[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.] Requirements: ISO, IEC