Sr. Design Quality Assurance Engineer
Share
Job Location:
Minnetonka, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit 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. 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. Bachelors degree in Biomedical Mechanical Electrical Engineering or related field 58 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) 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 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 youre excited about this role we encourage you to applyeven if youre 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 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. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: Senior ICYou Will:
You Have:
Our Benefits (there are more but here are some highlights):
Key Skills
- Test Cases
- Performance Testing
- Quality Assurance
- SOC
- Agile
- Debugging
- Jira
- Perl
- Software Testing
- Test Automation
- Scripting
- Selenium
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
