Senior/Principal Device Engineer
2 weeks ago
Position: Senior / Principal Device Engineer
Overview:
An innovative medical device organization is developing cutting-edge annular flow technologies designed to dramatically improve drug delivery by reducing injection forces and enabling high-viscosity formulations. The team partners with leading biopharma companies to advance next-generation combination products that allow safer, more efficient, and patient-friendly treatments.
Role Summary:
As a Senior or Principal Device Engineer , you will play a key role in guiding products from early-stage development to FDA submission and commercialization. You'll lead engineering initiatives that span design, testing, manufacturing, and regulatory documentation, contributing to a broad range of delivery systems - from subcutaneous and intravitreal injections to high-dose combination products.
Key Responsibilities:
- Lead device design from user needs through design freeze.
- Plan and execute verification testing, human factors studies, and risk mitigation.
- Oversee vendor selection, tooling, sterilization, and packaging development.
- Prepare and author technical documentation and data packages for regulatory submissions.
- Bachelor's degree or higher in a relevant engineering discipline.
- 5+ years of experience in medical device development.
- Proven expertise in areas such as:
- Design Controls and Risk Management
- Design Transfer
- Vendor Management (CROs, CMOs, testing partners)
- User Needs & Human Factors Engineering
- Verification and Validation
- Experience with needle-based injection device systems .
- Familiarity with applicable standards (ISO 11608, ISO 11040, ISO 10993, ISO 11135).
- Experience working in startups or small, fast-paced teams.
- Opportunity to make a visible impact on an innovative medical device platform.
- Competitive salary, early-employee equity, 401(k), and comprehensive health benefits.
- Title and compensation commensurate with experience.
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