Sr. Process & Operations Engineer

hims & hers
United States
Workplace: OnsiteFull timeUSD 130,000 - 150,000 annuallyFunction: Communications, PR & CommunityExperience: 8+ yearsEducation: bachelorsSkills: ["Cross-functional collaboration","Root cause analysis","Process optimization","Continuous improvement"]

Oversee contract manufacturing for a Class II FDA-regulated medical device, serving as the primary technical liaison between internal teams and CMOs. Lead day-to-day manufacturing performance, quality metrics, and execution while developing and validating manufacturing processes (including IQ/OQ/PQ), supporting design transfer, and driving CAPAs. Ensure compliance with 21 CFR Part 820, ISO 13485, and GMP, collaborate with R&D/Quality/Regulatory/Supply Chain, and drive continuous improvement using Lean and Six Sigma.

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FursaFursa
hims & hers
hims & hers
1 month ago

Sr. Process & Operations Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 16 hours agoStatus: Live

Job Summary

Oversee contract manufacturing for a Class II FDA-regulated medical device, serving as the primary technical liaison between internal teams and CMOs. Lead day-to-day manufacturing performance, quality metrics, and execution while developing and validating manufacturing processes (including IQ/OQ/PQ), supporting design transfer, and driving CAPAs. Ensure compliance with 21 CFR Part 820, ISO 13485, and GMP, collaborate with R&D/Quality/Regulatory/Supply Chain, and drive continuous improvement using Lean and Six Sigma.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Communications, PR & Community
Seniority: Mid level

Key Responsibilities

  • •Serve as primary technical operations lead for external contract manufacturers and critical suppliers, overseeing day-to-day performance, quality metrics, and execution.
  • •Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables, including characterization, validation, verification, and equipment qualification.
  • •Partner with R&D during product development and design transfer to ensure manufacturability and scalability.
  • •Lead root cause investigations and implement corrective and preventive actions (CAPAs) for manufacturing or process issues.
  • •Ensure manufacturing activities comply with FDA 21 CFR Part 820, ISO 13485, GMP, and internal quality procedures, including documentation completeness and supplier quality management.

Pay and Benefits

Salary: USD 130,000 - 150,000 annually
Perks:Health InsuranceDentalVisionParental LeavePaid Leave401kEspp

Key Requirements

  • •Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related).
  • •8+ years in process engineering, operations engineering, or manufacturing engineering in the medical device or diagnostics industry.
  • •Experience supporting Class II FDA-regulated medical devices in a GMP manufacturing environment.
  • •Direct experience managing or working closely with Contract Manufacturing Organizations (CMOs).
  • •Strong understanding of design controls, process validation (IQ/OQ/PQ), and FDA quality system regulations (21 CFR Part 820) plus ISO 13485, CAPA, and change control.
Experience:8+ yearsMedical devicesDiagnosticsRegulated manufacturingGMPFDA-regulatedISO 13485
Education:Bachelor's in Mechanical, Biomedical, Industrial, Manufacturing, or related field
Skills:Cross-functional collaborationRoot cause analysisProcess optimizationContinuous improvement
Tech Stack:FDA Quality System Regulations (21 CFR Part 820)ISO 13485GMPLeanSix SigmaIQ/OQ/PQ validationProcess validationCAPAChange controlDevice History Records (DHRs)Device History Records

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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