Sr. Product Development Engineer — Minneapolis, MN
Hims & Hers· OPERATIONS
Minnetonka, Minnesota$130k - $170kFull-timePosted 2mo ago
About the role
Senior Product Development Engineer for FDA-regulated medical devices and packaging, responsible for hands-on mechanical design, packaging development, V&V, human factors, and regulatory collaboration from concept through design transfer.
Responsibilities
- Hands-on design and development of medical devices, including concept generation, detailed design, prototyping, and design transfer to manufacturing.
- Create and maintain design compliant documentation, including design inputs, outputs, DHFs, and engineering change orders.
- Execute design verification and validation (V&V) activities, including test protocol authorship, execution, and reporting.
- Lead or support human factors engineering (HFE) activities, including use-related risk analysis and formative/summative usability testing.
- Apply risk management principles throughout the product development lifecycle.
- Develop and evaluate prototypes using appropriate fabrication methods; iterate rapidly based on testing and user feedback.
- Support design for production readiness and work with contract manufacturers and suppliers to optimize cost, quality, and scalability.
- Evaluate and qualify packaging materials, components, and configurations for device protection, usability, stability, and shipping integrity.
- Lead packaging qualification activities including seal strength testing, package integrity testing, and accelerated and real-time aging studies.
- Lead or support sterilization validation activities in partnership with external vendors and laboratories.
- Coordinate transportation and distribution simulation testing to ensure product integrity through the supply chain.
- Maintain complete packaging and device documentation within the DHF and DMR.
- Contribute to regulatory submissions through engineering documentation and technical file development.
- Collaborate with Quality, Regulatory Affairs, Operations, Supply Chain, and the Creative Design team to ensure device and packaging readiness for commercialization.
- Coordinate testing activities with external laboratories, sterilization vendors, and packaging suppliers.
- Assist Regulatory Affairs with submissions and documentation related to device, packaging, and sterilization.
- Participate in design reviews, internal audits, supplier assessments, and regulatory inspections as needed.
- Contribute to risk management activities related to the device, packaging, shipping, and product transport.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
- 8+ years of engineering experience, with a minimum of 4 years in FDA-regulated medical device or diagnostics product development.
- Working knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607 quality and packaging standards.
- Hands-on experience with design controls, DHF documentation, and design V&V.
- Experience authoring and executing packaging qualification or sterilization validation protocols and technical reports.
- Experience conducting human factors engineering (HFE) activities per FDA HE75 and IEC 62366-1, including use-related risk analysis and formative/summative usability testing.
- Proficiency in SolidWorks or equivalent 3D CAD software; experience with GD&T and tolerance stack-up analysis.
- Familiarity with risk management processes per ISO 14971.
- Strong written and verbal communication skills for cross-functional collaboration and technical documentation.
Skills
Required:Design controls and DHF documentationV&V planning and executionHuman factors engineering3D CAD (SolidWorks)Packaging qualification and sterilization validation
Benefits
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- Employee discounts on hims & hers & Apostrophe online products
- 401k benefits with employer matching contribution
- Offsite team retreats
Last updated Oct 21, 2026. Interested? Apply on the company site.
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