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Sr. Process & Operations Engineer — Minneapolis, MN

Hims & Hers· OPERATIONS
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Minnetonka, Minnesota$130k - $170kFull-timePosted 2mo 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/technical liaison between internal teams and CMOs to ensure regulatory, quality, and business requirements are met.

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 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 operational efficiency
  • Quality & Regulatory Compliance: Ensure all manufacturing activities comply with FDA QSR (21 CFR Part 820), ISO 13485, GMP, internal quality system procedures; Collaborate with Quality Assurance to address nonconformances, deviations, change controls, and audit findings; Support supplier qualification, supplier audits, and ongoing supplier quality management; Ensure manufacturing documentation, DHRs, and validation records are complete and compliant
  • Cross-Functional Collaboration: Work with R&D to transition products to commercial manufacturing; Partner with Supply Chain and Planning for production schedules, inventory management, and demand planning; Support Regulatory Affairs with manufacturing documentation for submissions and inspections; Coordinate with Packaging, Sterilization, and Logistics for release and shipment readiness
  • Operational Excellence: Establish and monitor KPIs related to manufacturing quality, throughput, scrap, and supplier performance; Drive continuous improvement with Lean/Six Sigma; Implement scalable operational processes; Assist in risk assessments and mitigation for 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 medical device or diagnostics industry
  • Experience supporting Class II FDA-regulated medical devices in GMP manufacturing
  • 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 EngineeringQuality & Regulatory Compliance

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 Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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