Head of Hardware Engineering (Medical Devices) f/m

Your responsibilities

• 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.

Employer requirements

• 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.

Optional

• 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 employer offers

• 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.