Sr. Design Quality Assurance Engineer

Department: QUALITY

Location: Minnetonka, Minnesota

Employment Type: FullTime

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role:

The Senior Design Quality Assurance Engineer is responsible for owning design quality strategy and execution across assigned medical device programs from concept through commercialization. This role provides technical leadership in design controls, risk management, and verification and validation (V&V), ensuring products meet safety, performance, and regulatory requirements. This role will report to the Director of Quality.

As the primary Design Quality representative on cross-functional teams, this individual influences product architecture decisions, drives inspection-ready documentation, and ensures robust risk mitigation throughout the product lifecycle.

You Will:

Design Control Leadership

• Own and lead design control strategy in compliance with FDA 21 CFR 820.30, ISO 13485, and applicable global regulations

• Facilitate design reviews and ensure phase-appropriate deliverables are complete, compliant, and audit-ready

• Serve as the design quality authority for assigned programs

Risk Management

• Lead development and maintenance of risk management files in accordance with ISO 14971

• Drive DFMEA, PFMEA, Hazard Analysis, and Usability risk activities to proactively identify and mitigate product and process risks

• Ensure risk controls are effectively implemented and verified

Verification & Validation Strategy

• Define and lead V&V strategy, including protocol development, statistical justification, test method validation, and final reporting

• Ensure traceability from user needs and design inputs through validationaudit and risk controls

Design History File & Change Management

• Own the integrity and completeness of the Design History File (DHF)

• Ensure alignment between DHF and Device Master Record (DMR) during design transfer

• Assess and approve design changes, including evaluation of risk, validation impact, and regulatory implications

Regulatory & Audit Support

• Partner with Regulatory Affairs to support submissions (e.g., 510(k), PMA supplements, EU technical documentation)

• Serve as subject matter expert during internal audits and external inspections

• Present and defend design control activities with regulatory bodies as needed

Cross-Functional Influence & Continuous Improvement

• Partner with R&D, Manufacturing, Quality, and Regulatory to embed quality principles throughout development

• Mentor junior engineers on design control and risk management best practices

• Identify and implement improvements to design quality processes, tools, and documentation standards

• Lead and own CAPAs related to design control activities, including root cause investigation, impact assessment on DHF and risk management files, implementation of corrective actions, and verification of effectiveness.

You Have:

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or related field

• 5–8+ years of experience in medical device development within Quality or R&D

• Demonstrated experience owning design controls and supporting at least one FDA 510(k) submission. In vitro diagnostic (IVD) experience preferred

• Deep understanding of FDA design controls, ISO 13485, and ISO 14971

• Strong proficiency in statistical methods, risk management tools, and root cause analysis

• Experience authoring complex protocols, validation reports, and SOPs

• Experience working within an electronic QMS (Qualio preferred)

• Excellent written and verbal communication skills

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles

• Unlimited PTO, company holidays, and quarterly mental health days

• Comprehensive health benefits including medical, dental & vision, and parental leave

• Employee Stock Purchase Program (ESPP)

• 401k benefits with employer matching contribution

• Offsite team retreats

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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