Eng II, Design Transfer
Core
Ensuring seamless design transfer of medical device products from concept to manufacturing, establishing test specifications, and maintaining compliance with regulatory standards.
Role type
Senior IC mechanical/electrical engineer (medical device design transfer)
Builds
Medical device products for respiratory and cardiac care (airway clearance, patient monitors)
Domain
Medical devices / Regulatory compliance / Manufacturing engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical/Electrical/Electronics/Bio-Medical/Industrial engineering, FDA regulations, ISO 14971 risk management, IEC 60601-1 compliance, DOORS/Polarion requirements management, Agile/PDLM, QFD/Pugh Matrix/CTQ/DFR/DFX methodologies, EMI/EMC, REACH/ROHS/Biocompatibility
Preferred skills
Experience with contract manufacturers, Notified Body audit support, multi-project delivery
Technologies
DOORS, Polarion, Agile, PDLM
Responsibilities
Establish standard methods for manufacturing testing and requirements; Compile and maintain Production Safety Test System Requirements (TSR); Create, review, and disposition manufacturing test specifications; Carry out risk management per EN ISO 14971; Lead compliance with IEC 60601-1 and collateral standards; Provide support during Notified Body audits; Collaborate with contract manufacturers and manufacturing sites to sustain validated status.
Seniority
Mid-Senior, hands-on IC