Hims & Hers
Sr. Engineer, Design Quality Assurance
$140K–$160K
Minnetonka, Minnesota · On-site · Senior · Full-time · Posted Aug 20, 2026
- Experience
- 5–8+ years; design assurance, new product development, or related medical-device / regulated-industry experience.
- Education
- Bachelor’s degree in mechanical or biomedical engineering (or other related technical discipline).
About the job
Supports medical-device design and development, quality assurance, and transfer of new products into manufacturing.
What you'll do
- Support design assurance activities, including risk management, design controls, post-market work, and design changes.
- Develop and maintain technical documentation, Design History Files, design inputs/outputs, and product risk-management tools.
- Support verification, validation, usability testing, and effective controls for Class II medical devices.
What they ask for
- Bachelor’s degree in mechanical or biomedical engineering, or another related technical discipline.
- 5–8+ years of experience in design assurance, new product development, or related medical-device or regulated-industry work.
- Demonstrated use of quality tools/methodologies and experience creating detailed technical documents.
- Ability to collaborate in a mixed onsite and remote environment.
Nice to have
- Experience developing and/or manufacturing Class II medical devices.
- Understanding of ISO 13485, ISO 14971, and Quality System Regulations, focused on Design Controls and Risk Analysis.
Pay
$140K – $160K (base salary)
Tools
ISO 13485, ISO 14971
Model-written summary · the original posting is authoritative