Technical Lead, Product Development
Core
Provide technical leadership for medical-device and combination-product prototyping and feasibility activities, applying expertise in mechanical, plastic, electrical, software, and human factors engineering to develop integrated product solutions.
Role type
Senior Technical Lead (Medical Device Engineering)
Builds
Integrated medical-device and combination-product solutions
Domain
Medical Devices / Biotechnology
Required skills
Mechanical and plastic-part design, Injection molding, DFM/DFA/DFx, Tolerance analysis, Design controls (ISO 14971, ISO 13485), Design verification and validation, Cross-functional technical leadership, Risk management, Regulatory submission impact assessment
Preferred skills
Principal investigator experience, Out-of-the-box problem solving, Patent authorship, Scientific conference presentation
Technologies
Injection molding, DFM, DFA, DFx, ISO 14971, ISO 13485, DHF
Responsibilities
Lead prototyping and feasibility activities for medical-device programs, Develop and evaluate product concepts and technical solutions, Collaborate with electrical, software, human factors, quality, regulatory, and manufacturing partners, Resolve technical challenges and design tradeoffs, Plan and document feasibility studies and prototype evaluations, Assess impact of design changes on product requirements and regulatory submissions
Seniority
Senior, hands-on IC with strategic influence
