Responsibilities
- Lead electrical system design for clinical development of advanced drug delivery systems (e.g., on-body injectors, subcutaneous ambulatory infusion pumps, electromechanical systems).
- Partner with external development partners on electronic component design and development.
- Execute feasibility/initial development: needs definition, requirements, design fundamentals assessment, technology landscaping.
- Evaluate system architecture and assess electrical component testing/analysis.
- Perform electronics assessments: circuit design, PCB assessment, circuit analysis, design margin evaluation, and define testing requirements.
- Support system integration, reliability assessments, verification testing, and design validation.
- Create and maintain design history file documentation (design inputs/outputs, protocols, task analysis, risk assessments).
- Support test planning/setup and engineering confidence tests.
- Collaborate with clinical, project development, regulatory, quality, and operations teams; work across disciplines (mechanical, software, systems).
- Stay current on technology trends; assess relevance and partner with vendors on technology roadmaps.
- Drive continuous improvement and use project management/stage-gate processes.
Qualifications
- BS in Electrical Engineering (or equivalent) with typically 10+ years; or MS with typically 8+ years.
- Demonstrated medical device or combination product development experience.
- Highly desirable: subcutaneous injection devices, electromechanical devices, digital/connected health.
- Expertise in electrical system design for drug delivery; advanced circuit/PCB/embedded systems.
- Proficient with design tools, simulation software, and analytical modeling.
- Knowledge of regulatory/industry standards (e.g., 21 CFR 820.30, ISO 13485, MDR).
- Experience with design verification and validation in regulated environments.
- Strong technical leadership, judgment, communication, collaboration, project management, risk identification, and ability to work independently.
Benefits (if applicable)
- Paid time off; medical/dental/vision insurance; 401(k); eligibility for short-term incentive programs.