HH
$130,000 – $150,000
Listed on Hims and Hers’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
This role designs and develops FDA-regulated medical devices and their packaging systems, from initial concept through manufacturing transfer. It suits experienced mechanical or biomedical engineers who are comfortable with regulatory compliance, design documentation, and cross-functional collaboration in a fast-moving healthcare setting.
Our summary, not Hims and Hers’s wording. The full posting is on their site.
Skills this role names
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What they ask for
Required
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or related field
- 8+ years of engineering experience
- 4+ years in FDA-regulated medical device or diagnostics development
- Working knowledge of 21 CFR 820, ISO 13485, and ISO 11607
- Hands-on experience with design controls and DHF documentation
- Experience authoring and executing packaging qualification or sterilization validation protocols
- Experience conducting human factors engineering per FDA HE75 and IEC 62366-1
- Proficiency in SolidWorks or equivalent 3D CAD
- Experience with GD&T and tolerance stack-up analysis
- Familiarity with ISO 14971 risk management
- Strong written and verbal communication skills
Nice to have
- Experience with IVD or diagnostic device development
- Experience with diagnostic specimen collection or sample integrity
- Familiarity with CLIA regulations or point-of-care diagnostic platforms
- Advanced HFE experience including full summative usability study design
- Experience with Class II or Class III medical devices
- Exposure to notified body or FDA interaction during submission