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Hims & Hers, a publicly traded health and wellness platform (NYSE: HIMS), is seeking a Senior Process & Operations Engineer to oversee contract manufacturing operations for Class II FDA-regulated medical devices used in capillary blood collection for laboratory diagnostics.
You will serve as the primary operational and technical liaison between internal teams and Contract Manufacturing Organizations (CMOs), ensuring manufacturing processes, product quality, and operational performance meet all regulatory, quality, and business requirements. This role is cross-functional, requiring collaboration with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support product commercialization, process scalability, validation, and continuous improvement.
Key responsibilities include:
**Contract Manufacturing Oversight:** Lead day-to-day manufacturing performance and quality metrics at CMOs; ensure processes consistently meet product specifications and production targets; drive accountability on timelines, deviations, CAPAs, and continuous improvement.
**Process Engineering & Manufacturing Support:** Develop, optimize, and sustain manufacturing processes for Class II medical devices; partner with R&D on design transfer and manufacturability; support process characterization, validation, and verification (IQ/OQ/PQ); lead root cause investigations and CAPA implementation; monitor process performance for yield improvement and cost reduction.
**Quality & Regulatory Compliance:** Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and GMP requirements; collaborate with Quality Assurance on nonconformances and deviations; support supplier qualification and audits; maintain complete Device History Records and validation documentation.
**Cross-Functional Collaboration:** Transition new products from development to commercial manufacturing; partner with Supply Chain on production schedules and demand planning; support Regulatory Affairs with manufacturing documentation; coordinate with Packaging, Sterilization, and Logistics teams.
**Operational Excellence:** Establish and monitor KPIs for manufacturing quality, throughput, and supplier performance; drive continuous improvement using Lean/Six Sigma methodologies; support scalable operational processes; assist in risk assessments for manufacturing and supply continuity.
**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 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 regulated environments
**Special Conditions:** This position requires working with Hazardous Drugs (HD) and wearing appropriate PPE (gloves, respiratory protection, gown). Medical approval required to wear respiratory protection (N95, full face respirator, SCBA, or PAPR). Physical exertion required: walking up to 50%, standing up to 100%, squatting/bending up to 20%, lifting up to 80% of the time for up to 12-hour shifts; must be able to lift up to 50 lbs. Candidates must confirm understanding of potential reproductive risks (teratogenicity, carcinogenicity, reproductive effects) of handling hazardous drugs.
