Sr. Design Quality Assurance Engineer

Hims & Hers • Minnetonka, MN

7h

About The Position

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.

Requirements

• 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

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level