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Sr. Process & Operations Engineer — Boston, MA

Hims & Hers· OPERATIONS
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Boston, Massachusetts$130k - $170kFull-timePosted 5d ago

About the role

Senior Process / Operations Engineer – Regulated Devices responsible for overseeing contract manufacturing operations for a Class II FDA-regulated medical device, acting as the primary operational liaison with CMOs to ensure regulatory-compliant manufacturing, quality, and scalability.

Responsibilities

  • Contract Manufacturing Oversight: Serve as the primary technical operations lead for external contract manufacturers and critical suppliers; Oversee day-to-day manufacturing performance, quality metrics, and operational execution at CMOs; Ensure manufacturing processes consistently meet product specifications, quality standards, and production targets; Drive accountability with manufacturing partners regarding timelines, deviations, CAPAs, and continuous improvement initiatives
  • Process Engineering & Manufacturing Support: Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables; Partner with R&D during product development and design transfer activities to ensure manufacturability and scalability; Support process characterization, validation, and verification activities, including IQ/OQ/PQ validation; Process capability studies; Equipment qualification; Manufacturing line readiness; Lead root cause investigations and CAPAs; Monitor process performance and identify opportunities for yield improvement, cost reduction, and efficiency
  • Quality & Regulatory Compliance: Ensure manufacturing activities comply with FDA QSR (21 CFR Part 820), ISO 13485, GMP, internal quality procedures; Collaborate with QA on nonconformances, deviations, change controls, audit findings; Support supplier qualification and ongoing supplier quality management; Ensure DHRs and validation records are complete and compliant
  • Cross-Functional Collaboration: Work with R&D to transition products to manufacturing; Partner with Supply Chain and Planning for production schedules and inventory; Support Regulatory Affairs with manufacturing documentation for submissions and inspections; Coordinate with Packaging, Sterilization, and Logistics for product release and shipments
  • Operational Excellence: Establish and monitor KPIs for manufacturing quality, throughput, scrap, and supplier performance; Drive continuous improvement with Lean/Six Sigma; Implement scalable processes as the company grows; Support risk assessments related to manufacturing and supply continuity

Qualifications

  • Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field)
  • 8+ years of experience in process/operations/manufacturing engineering within 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), FDA QSR (21 CFR Part 820), ISO 13485, CAPA and change control systems
  • Experience collaborating with Quality, Regulatory, and R&D teams in a regulated environment

Skills

Required:Contract Manufacturing OversightProcess Engineering & ValidationQuality & Regulatory Awareness

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
  • Hazardous Drugs handling with PPE and medical approval for respirators
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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