Sr. Design Quality Assurance Engineer

Hims & Hers
Any Location, MN
Category Engineering
Job Description
Hims & Hers is a leading health and wellness platform seeking a Sr. Design Quality Assurance Engineer to own design quality strategy and execution across assigned medical device programs from concept through commercialization.

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
  • 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

Benefits

  • Competitive salary
  • Equity compensation for full-time roles
  • Unlimited PTO
  • Company holidays
  • Quarterly mental health days
  • Comprehensive health benefits
  • Parental leave
  • Employee Stock Purchase Program (ESPP)
  • 401k benefits with employer matching contribution
  • Offsite team retreats
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