Head of Hardware Engineering (Medical Devices) f/m @ Antal

Full Time

Job description

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 diagnostic devices, and/or medical device software development.

Required skills

iso iec 13485 npi ivd dfm/dft contract manufacturing emc/emi design transfer medical device software development 14971 62304 design controls 61010 60601 point-of-care diagnostic devices

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