Head of Hardware Engineering (Medical Devices) f/m

Antal is a leader in recruitment of specialists and managers as well as HR consulting. The brand operates in 35 countries and has been active in Poland since 1996, employing over 130 professional recruitment consultants specialized in various sectors and positions.

• 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.
• Experience in a startup or scale-up environment.

• 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.