Sr. Engineer, Design Quality Assurance

hims & hers
United States
Workplace: OnsiteFull timeUSD 140,000 - 160,000 annuallyFunction: QA, Test & Release EngineeringExperience: 5+ yearsSkills: ["Problem-solving","Initiative","Cross-functional collaboration","Communication","Bias for action","Ability to write technical documentation"]

Support sustaining and new product design and development by ensuring effective transfer of design work into manufacturing for Class II medical devices. Apply systematic problem-solving to identify and resolve quality issues, participate in design change analysis, and support design assurance activities including risk management, design controls, validation, and statistical techniques. Maintain design documentation and risk tools (DHFs, Design Inputs/Outputs, Hazard Analysis, FMEAs) and partner cross-functionally with R&D to implement controls based on risk, customer needs, and manufacturing input.

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FursaFursa
hims & hers
hims & hers
1 day ago

Sr. Engineer, Design Quality Assurance

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Source: Company careers pageValidated by: Fursa AI
Last checked: 9 hours agoStatus: Live

Job Summary

Support sustaining and new product design and development by ensuring effective transfer of design work into manufacturing for Class II medical devices. Apply systematic problem-solving to identify and resolve quality issues, participate in design change analysis, and support design assurance activities including risk management, design controls, validation, and statistical techniques. Maintain design documentation and risk tools (DHFs, Design Inputs/Outputs, Hazard Analysis, FMEAs) and partner cross-functionally with R&D to implement controls based on risk, customer needs, and manufacturing input.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Identify, prioritize, communicate, and resolve quality issues using systematic problem-solving methodologies.
  • •Work in a cross-functional team to implement effective controls for realization of Class II medical devices.
  • •Write and maintain technical documentation for procedure execution, technical rationale, and evidence of the development process.
  • •Support design assurance priorities including Risk Management, Design Controls, and post-market risk activities as needed.
  • •Develop and maintain design and risk-management artifacts, including Design History File, Design Input/Output documentation, and product risk management tools (Hazard Analysis, Fault Tree, FMEAs).

Pay and Benefits

Salary: USD 140,000 - 160,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVisionPaid LeaveParental Leave401k

Key Requirements

  • •Minimum bachelor’s degree in mechanical or biomedical engineering (or related technical discipline).
  • •5–8+ years of experience in design assurance, new product development, or related medical device / regulated industry experience.
  • •Demonstrated use of quality tools/methodologies.
  • •Ability to effectively work and collaborate in a mixed onsite + remote environment.
  • •Strong communication skills (verbal & written) and demonstrated experience creating detailed technical documents.
Experience:5+ yearsMedical devicesRegulated industry
Education:
Skills:Problem-solvingInitiativeCross-functional collaborationCommunicationBias for actionAbility to write technical documentation
Certifications:ISO 13485ISO 14971
Tech Stack:ISO 13485ISO 14971Risk ManagementDesign ControlsRisk AnalysisDesign History FileDesign InputDesign OutputHazard AnalysisFault TreeFMEAsVerificationValidationUsability testingStatistical techniques

Company Brief

hims & hers
A telehealth and consumer wellness platform offering personalized care and products across sexual health, hair, mental health, dermatology, weight loss and primary care via digital consultations, prescriptions, and fulfillment.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Francisco, United States
Founded: 2017
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