Sr. Process & Operations Engineer

Hims & Hers • Menlo Park, CA

1d • $130,000 - $150,000

About The Position

The Senior Process / Operations Engineer – Regulated Devices oversees contract manufacturing operations for a Class II FDA-regulated medical device used to collect capillary blood from a patient’s upper arm into a collection tube for laboratory diagnostic analysis. The role is the primary operational and technical liaison between internal teams and Contract Manufacturing Organizations (CMOs), ensuring manufacturing processes, product quality, and operational performance meet regulatory, quality, and business requirements.

The engineer works cross-functionally with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support product commercialization, process scalability, validation, and continuous improvement. The position requires experience in medical device process engineering, supplier and CMO management, regulated manufacturing, and FDA and ISO quality system requirements.

The position involves working with Hazardous Drugs and wearing required PPE, including gloves, respiratory protection, and a gown. Medical approval is required to wear respiratory protection. The role has physical demands that may include walking, standing, squatting, bending, and lifting, including lifting up to 50 pounds. Associates must understand the potential reproductive, carcinogenic, and teratogenic risks of handling certain Hazardous Drugs.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field).
• 8+ years of experience in process engineering, operations engineering, or 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 Quality System Regulations (21 CFR Part 820), ISO 13485, CAPA, and change control systems.
• Experience collaborating with Quality, Regulatory, and R&D teams in a regulated environment.
• Ability to wear required PPE, including respiratory protection, while working with Hazardous Drugs.
• Medical approval to wear negative- or positive-pressure respiratory protection, including N95, full-face respirator, SCBA, or PAPR.
• Ability to meet stated physical demands, including lifting up to 50 pounds.
• Willingness to confirm understanding of the potential risks of handling certain Hazardous Drugs.

Responsibilities

• 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 manufacturing partner accountability for timelines, deviations, CAPAs, and continuous improvement initiatives.
• Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables.
• Partner with R&D during product development and design transfer to support manufacturability and scalability.
• Support process characterization, validation, and verification, including IQ/OQ/PQ validation, process capability studies, equipment qualification, and manufacturing line readiness.
• Lead root-cause investigations and implement corrective and preventive actions related to manufacturing or process issues.
• Monitor process performance and identify opportunities for yield improvement, cost reduction, and operational efficiency.
• Ensure manufacturing activities comply with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and internal quality system procedures.
• Collaborate with Quality Assurance on nonconformances, deviations, change controls, and audit findings.
• Support supplier qualification, supplier audits, and ongoing supplier quality management.
• Ensure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant.
• Work with R&D to transition new products from development into commercial manufacturing.
• Partner with Supply Chain and Planning teams on production schedules, inventory management, and demand planning.
• Support Regulatory Affairs with manufacturing documentation for regulatory submissions and inspections.
• Coordinate with Packaging, Sterilization, and Logistics teams for product release and shipment readiness.
• Establish and monitor KPIs for manufacturing quality, throughput, scrap, and supplier performance.
• Drive continuous improvement using Lean, Six Sigma, or similar methodologies.
• Support implementation of scalable operational processes as the company grows.
• Assist with manufacturing and supply continuity risk assessments and mitigation.

Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits, including medical, dental, and vision insurance, and parental leave.
• Employee Stock Purchase Program (ESPP).
• Employee discounts on hims & hers and Apostrophe online products.
• 401(k) benefits with employer matching contribution.
• Offsite team retreats.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior