Hims & Hers
Sr. Product Development Engineer — Menlo Park, CA
$130K–$170K
Menlo Park, California · On-site · Senior · Full-time · Posted Oct 15, 2026
- Experience
- 8+ years of engineering experience, with a minimum of 4 years in FDA-regulated medical device or diagnostics product development.
- Education
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
About the job
Develops FDA-regulated consumer medical devices and packaging from concept through design transfer, ensuring technical, regulatory, usability, and performance requirements are met.
What you'll do
- Design, prototype, verify, and transfer medical devices and packaging to manufacturing; maintain design documentation.
- Lead or support packaging qualification, sterilization validation, usability testing, and risk management activities.
- Collaborate with cross-functional teams, suppliers, and laboratories on commercialization readiness and regulatory documentation.
What they ask for
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
- 8+ years of engineering experience, including at least 4 years in FDA-regulated medical device or diagnostics product development.
- Working knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607; hands-on experience with design controls, DHF documentation, and design V&V.
- Experience with packaging qualification or sterilization validation protocols and reports; HFE activities per FDA HE75 and IEC 62366-1; proficiency in SolidWorks or equivalent 3D CAD software.
Nice to have
- Experience with diagnostic devices, specimen collection, or IVD regulations and platforms.
- Advanced HFE experience, or experience with Class II or Class III devices and FDA or notified body submissions.
Pay
$130K – $170K • Multiple Ranges (currency and whether base salary or total pay not stated)
Tools
21 CFR 820 (QSR), ISO 13485, ISO 11607, FDA HE75, IEC 62366-1, SolidWorks, GD&T, ISO 14971
Model-written summary · the original posting is authoritative