# Sr. Product Development Engineer

Hiring organization: [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers)

Canonical page: https://career.thegoodapps.co/jobs/071f32d7-d002-494b-83f9-99748696ae4d

Listed on Hims and Hers's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: Minnetonka, MN
- Salary: 130000 – 150000 USD per year

## Summary

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._

## Skills named

Geometric Dimensioning and Tolerancing (GD&T), ISO 13485, SolidWorks

## 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

Apply on Hims and Hers's site: https://jobs.ashbyhq.com/hims-and-hers/c9b7237f-b6db-467c-bcb2-ecf75a1ec685/application