Senior Electrical Engineer, Combination Product Development
Core
Lead electrical system design for clinical development of advanced drug delivery systems, including on-body injectors and subcutaneous ambulatory infusion pumps.
Role type
Senior IC electrical engineer (medical devices)
Builds
Electromechanical drug delivery systems and platform technologies
Domain
Medical devices / Drug delivery systems
Deliverable
production ML models | product features | infrastructure
Required skills
Electrical system design, circuit design, PCB design, embedded systems, system architecture evaluation, design verification and validation, regulatory compliance (21 CFR 820.30, ISO 13485, MDR), project management
Preferred skills
Experience with subcutaneous injection devices, electromechanical devices, digital/connected health technologies, design tools and simulation software
Technologies
PCB design tools, simulation software, analytical modeling tools
Responsibilities
Execute feasibility and initial development activities including needs definition and requirements assessment, conduct system architecture evaluation and testing, support system integration and reliability assessments, provide engineering analysis and design history file documentation, collaborate with cross-functional teams to ensure regulatory alignment
Seniority
Senior, hands-on IC