# Sr. Engineer, Design Quality Assurance

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

Canonical page: https://career.thegoodapps.co/jobs/e19891d7-7146-4939-a64e-40d5022e96fb

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

- Seniority: Senior
- Location: Minnetonka, MN
- Salary: 140000 – 160000 USD per year

## Summary

A senior quality assurance engineer role supporting medical device design, development, and manufacturing at a digital health company. This suits experienced engineers in regulated industries who want to apply design controls, risk management, and validation expertise in a fast-paced environment.

_Our summary, not Hims and Hers's wording._

## Skills named

Failure Mode and Effects Analysis (FMEA), ISO 13485, Risk Management, Statistical Analysis, Technical Documentation

## Required

- Bachelor's degree in mechanical, biomedical, or related engineering discipline
- 5-8+ years in design assurance, new product development, or medical device/regulated industry experience
- Self-motivated problem-solver with bias for action
- Strong verbal and written communication
- Demonstrated use of quality tools and methodologies
- Ability to work in mixed onsite and remote environment
- Experience creating detailed technical documents

## Nice to have

- Experience developing or manufacturing Class II medical devices
- Understanding of ISO 13485, ISO 14971, and Quality System Regulations with focus on Design Controls and Risk Analysis
- Experienced problem-solving and facilitation skills
- Adaptability and collaboration in team or self-directed settings
- Experience with design changes, complaint management, and corrective action

Apply on Hims and Hers's site: https://jobs.ashbyhq.com/hims-and-hers/7d97f3d0-f544-49b0-a618-4dd1b7569283/application