Senior Electrical Engineer, Combination Product Development

What you'll do

• Lead electrical system design for advanced drug delivery systems including on-body injectors and infusion pumps.
• Execute feasibility studies, requirements definition, and technology landscaping for new device platforms.
• Perform electronics design assessments including circuit analysis, PCB evaluation, and testing requirement definitions.
• Conduct system integration activities, reliability assessments, and verification testing to ensure product robustness.
• Generate engineering analysis and documentation for design history files, including risk assessments and test protocols.
• Manage technical relationships with external development partners to oversee the production of electronic components.
• Coordinate with cross-functional teams in mechanical, software, and systems engineering to resolve complex technical issues.
• Monitor technology trends and partner with vendors to evaluate future roadmaps for combination products.

What we're looking for

• BS in Electrical Engineering or equivalent with 10+ years of experience, or MS in Electrical Engineering with 8+ years of experience.
• Demonstrated experience in medical devices or combination product development.
• Expertise in electrical system design for drug delivery systems.
• Advanced understanding of circuit design, PCB design, and embedded systems (experience from concept to launch is preferred).
• Proficiency with design tools, simulation software, and analytical modeling techniques.
• Solid knowledge of global regulatory requirements and industry standards such as 21 CFR 820.30, ISO 13485, and MDR.
• Experience with design verification and validation protocols in regulated environments.
• Prior experience with subcutaneous injection devices, electromechanical devices, or digital/connected health technologies (preferred).