Sr. Design Quality Assurance Engineer

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 LeadershipOwn and lead design control strategy in compliance with FDA 21 CFR 820.30, ISO 13485, and applicable global regulationsFacilitate design reviews and ensure phase-appropriate deliverables are complete, compliant, and audit-readyServe as the design quality authority for assigned programsRisk ManagementLead development and maintenance of risk management files in accordance with ISO 14971Drive DFMEA, PFMEA, Hazard Analysis, and Usability risk activities to proactively identify and mitigate product and process risksEnsure risk controls are effectively implemented and verifiedVerification & Validation StrategyDefine and lead V&V strategy, including protocol development, statistical justification, test method validation, and final reportingEnsure traceability from user needs and design inputs through validationaudit and risk controlsDesign History File & Change ManagementOwn the integrity and completeness of the Design History File (DHF)Ensure alignment between DHF and Device Master Record (DMR) during design transferAssess and approve design changes, including evaluation of risk, validation impact, and regulatory implicationsRegulatory & Audit SupportPartner 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 inspectionsPresent and defend design control activities with regulatory bodies as neededCross-Functional Influence & Continuous ImprovementPartner with R&D, Manufacturing, Quality, and Regulatory to embed quality principles throughout developmentMentor junior engineers on design control and risk management best practicesIdentify and implement improvements to design quality processes, tools, and documentation standardsLead 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 field5–8+ years of experience in medical device development within Quality or R&DDemonstrated experience owning design controls and supporting at least one FDA 510(k) submission. In vitro diagnostic (IVD) experience preferredDeep understanding of FDA design controls, ISO 13485, and ISO 14971Strong proficiency in statis ... (truncated, view full listing at source)