Senior Design Assurance Engineer (Medical Devices)

Location: Minnetonka, Minnesota, United States; on-site

Salary: $140,000–$160,000 annually for US-based candidates; equity compensation may also be available.

Company

hims & hers is a public health and wellness platform providing personalized access to diagnosis, treatment, and healthcare products.

What you will do

• Support sustaining and new product design and development activities and the transfer of Class II medical devices into manufacturing.
• Identify, prioritize, communicate, and resolve quality issues using systematic problem-solving methods.
• Support Risk Management, Design Controls, post-market activities, verification, validation, usability testing, and design change processes.
• Create and maintain Design History Files, product specifications, component specifications, prints, and other technical documentation.
• Develop and maintain hazard analyses, fault trees, FMEAs, and other product risk management tools.
• Partner with R&D and cross-functional teams on design controls, manufacturing input, risk analysis, and value improvement.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical discipline.
• 5–8+ years of experience in design assurance, new product development, medical devices, or another regulated industry.
• Experience with design controls, risk analysis, quality tools, validation, and statistical techniques.
• Understanding of ISO 13485, ISO 14971, and Quality System Regulations.
• Experience creating detailed technical documents, managing design changes, handling complaints, and supporting corrective actions.
• Ability to work in a mixed on-site and remote environment and comply with hazardous drug handling, PPE, respirator medical approval, and physical requirements.

Nice to have

• Experience developing or manufacturing Class II medical devices.
• Experience facilitating structured problem-solving processes.

Culture & Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited paid time off, company holidays, and quarterly mental health days.
• Medical, dental, and vision coverage with parental leave.
• Employee Stock Purchase Program and 401(k) with employer matching contribution.
• Employee discounts on hims & hers and Apostrophe products and offsite team retreats.