Senior Electrical Engineer, Combination Product Development

What you'll do

• Lead electrical system design for clinical development of advanced drug delivery systems and electromechanical devices.
• Execute feasibility activities including needs definition, requirements assessment, and technology landscaping.
• Conduct system architecture evaluations and perform electronics design assessments for circuits and PCBs.
• Support system integration, reliability assessments, and design validation to ensure products meet technical goals.
• Provide engineering analysis and design history file documentation including risk assessments and test protocols.
• Partner with external development partners to manage electronic component design and technology roadmaps.
• Collaborate with cross-functional teams to ensure development deliverables meet regulatory standards and quality expectations.
• Drive department continuous improvement initiatives to maximize process efficiencies and project success.

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.
• Demonstrated expertise in electrical system design for drug delivery systems.
• Advanced understanding of circuit design, PCB design, and embedded systems.
• Experience having designed and developed electrical systems from concept through product launch (preferred).
• Prior experience with subcutaneous injection devices, electromechanical devices, or digital/connected health technologies (preferred).
• Solid knowledge of global regulatory requirements and industry standards such as 21 CFR 820.30, ISO 13485, and MDR.
• Proficiency with design tools, simulation software, and analytical modeling techniques.