Senior Systems Engineer
About The Position
We are seeking an experienced Senior Systems Engineer to support client device development programs focused on autoinjector and combination products. The successful candidate will serve as an extension of the client team, leading day-to-day development activities, managing design control deliverables, coordinating external partners, and ensuring program objectives are achieved. The ideal candidate brings deep hands-on experience in medical device and combination product development, with the ability to independently manage design control activities, risk management deliverables, technical documentation, and cross-functional project execution while contributing to overall program strategy.
Requirements
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
- Approximately 7–10 years of relevant experience in device or combination product development.
- Direct, hands-on autoinjector development and commercialization experience.
- Experience with combination product design controls and risk management.
- Willingness and ability to perform detailed, hands-on execution work in addition to any strategic input.
- Strong project management skills, including schedule development and cross-functional coordination.
- Strong written and verbal communication skills.
Responsibilities
- Support autoinjector and combination product development activities across multiple programs.
- Develop and maintain integrated project schedules and Gantt charts.
- Coordinate activities across device vendors, fill-finish partners, assembly sites, and other suppliers.
- Prepare and manage design control and risk management deliverables.
- Draft development plans, verification plans, and supporting technical documentation.
- Manage day-to-day execution of assigned programs while receiving strategic direction from client leadership.
- Work independently on design control processes and deliverables.
- Communicate effectively across technical and cross-functional teams.
Benefits
- Medical and dental insurance
- Paid vacation time
- 401(k) after 90 days
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What This Job Offers
Job Type
Full-time
Career Level
Senior
