Responsibilities
- Lead electrical system design for clinical development of drug-device combination products (e.g., on-body injectors, subcutaneous ambulatory infusion pumps, other electromechanical systems).
- Partner with external development partners on electronic components design and development.
- Execute feasibility/initial development (needs definition, requirements, design fundamentals assessment, technology landscaping).
- Perform system architecture evaluation (electrical component design, testing, analysis).
- Conduct electronics design assessments (circuit design, PCB assessment, circuit analysis, design margins, testing requirements).
- Support integration, reliability assessments, verification testing, and design validation.
- Prepare design documentation (design inputs/outputs, protocols, task analysis, risk assessments).
- Support test plans/setups and engineering confidence tests with lab and verification teams.
- Collaborate cross-functionally (clinical, project development, regulatory, quality, operations; mechanical/software/systems engineering) to meet regulatory and quality expectations.
- Track technology trends, evaluate vendor roadmaps, drive continuous improvement, and use stage/gate project management.
Qualifications
- BS in Electrical Engineering (or equivalent) + typically 10+ years; or MS + typically 8+ years.
- Demonstrated experience in medical devices or combination product development.
- Highly desirable: subcutaneous injection devices, electromechanical devices, digital/connected health.
- Expertise in electrical system design; advanced circuit/PCB/embedded systems; concept-to-launch experience is a plus.
- Proficiency with design tools/simulation/analytical modeling.
- Knowledge of regulatory/standards (e.g., 21 CFR 820.30, ISO 13485, MDR) and design verification/validation in regulated environments.