Medical Device & Combination Product Development, Associate Director
Core
Lead the end-to-end development of drug-delivery devices and combination products from feasibility through commercialization readiness.
Role type
Associate Director, hands-on technical leader
Builds
Mechanical, electromechanical, wearable, on-body, and connected drug-delivery systems
Domain
Biotechnology / Medical Device Engineering
Deliverable
production ML models | product features
Required skills
Drug-delivery system development, Medical device design controls, ISO 13485/14971 regulatory knowledge, Risk management (FMEA, ISO 14971), Human factors/usability engineering, Mechanical and electromechanical design, Matrixed team leadership, Supplier/partner management
Preferred skills
Clinical study support, FDA combination-product submissions (IND, BLA, NDA), Medical device software lifecycle (IEC 62304), Battery-operated/electronically controlled systems, IEC 60601 standards, Global development programs
Technologies
None explicitly listed beyond standards
Responsibilities
Lead device and combination-product development activities, Define integrated development strategies, Translate clinical requirements into design inputs, Provide technical leadership for device architecture, Lead design-control activities, Apply risk-management principles, Develop verification and validation strategies, Partner with Human Factors and Usability Engineering, Support clinical-use readiness, Partner with suppliers, Ensure lifecycle and change-control requirements, Collaborate with cross-functional teams, Mentor and develop engineers
Seniority
Senior, hands-on IC with leadership responsibilities