Sr. Process & Operations Engineer — Menlo Park, CA

The role

The Senior Process / Operations Engineer oversees contract manufacturing operations for a Class II FDA-regulated medical device. This role acts as the technical liaison between internal teams and Contract Manufacturing Organizations to ensure manufacturing processes and product quality meet regulatory and business requirements.

What you will do

• 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
• Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables
• Partner with R&D during product development and design transfer activities
• Support process characterization, validation, and verification activities including IQ/OQ/PQ
• Lead root cause investigations and implementation of CAPAs
• Monitor process performance for yield improvement, cost reduction, and operational efficiency
• Ensure manufacturing activities comply with FDA, ISO 13485, and GMP requirements
• Collaborate with Quality Assurance to address nonconformances, deviations, and change controls
• Establish and monitor KPIs related to manufacturing quality, throughput, scrap, and supplier performance

Required qualifications

• 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)
• Understanding of design controls
• Understanding of process validation (IQ/OQ/PQ)
• Understanding of FDA Quality System Regulations (21 CFR Part 820)
• Understanding of ISO 13485
• Understanding of CAPA and change control systems
• Experience collaborating with Quality, Regulatory, and R&D teams in a regulated environment

Nice to have

• Experience using Lean or Six Sigma methodologies

Benefits

• Competitive salary & equity compensation
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats

Before you apply

• Requires working with Hazardous Drugs (HD) and wearing Personal Protective Equipment (PPE)
• Requires medical approval to wear respiratory protection
• Requires physical exertion including standing up to 100% of the time and lifting up to 50lbs
• Must be willing to confirm understanding of potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs

About the company

Hims & Hers is a health and wellness platform that provides access to personalized, affordable healthcare. It is a public company traded on the NYSE under the ticker symbol HIMS.