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Sr. Engineer, Design Quality Assurance

Hims & Hers· QUALITY
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Minnetonka, Minnesota$140k - $160kFull-timePosted 2mo ago

About the role

Senior Design Assurance Engineer supporting sustaining and new product development, ensuring effective transfer of new products into manufacturing within a fast-paced, regulatory medical device environment.

Responsibilities

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Acts as an effective team member in supporting quality disciplines, decisions, and practices.
  • Work within a cross-functional team to identify and implement effective controls for realization of Class II medical devices.
  • Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
  • Support Design Assurance activities as related to Risk Management, Design Controls, and other DA related priorities.
  • Support Post Market activities, as necessary, of risk based on post-market signals.
  • Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
  • Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
  • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs).
  • Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Partner cross-functionally to identify and support value improvement efforts to support business goals.

Qualifications

  • Minimum of a bachelor’s degree in mechanical or biomedical engineering (or other related technical discipline).
  • 5 - 8+ years of experience in design assurance, new product development or related medical device / regulated industry experience.
  • Self-motivated with a passion for solving problems and a bias for action.
  • Strong communication skills (verbal & written).
  • Demonstrated use of Quality tools/methodologies.
  • Ability to effectively work and collaborate in a mixed onsite + remote environment.
  • Demonstrated experience creating detailed technical documents.

Skills

Required:Quality tools and methodologiesDesign ControlsRisk ManagementDocumentationValidation and usability testingCommunication

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)
  • Employee discounts on hims & hers & Apostrophe online products
  • 401k benefits with employer matching contribution
  • Offsite team retreats
Last updated Aug 26, 2026. Interested? Apply on the company site.

About Hims & Hers

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