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Hims & Hers, a publicly traded healthcare 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 is a cross-functional role working with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners.
Key responsibilities include:
**Contract Manufacturing Oversight:** Serve as the primary technical operations lead for external CMOs and critical suppliers. Oversee day-to-day manufacturing performance, quality metrics, and operational execution. Ensure processes consistently meet product specifications and production targets. Drive accountability regarding 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 during product development and design transfer to ensure manufacturability and scalability. Support process characterization, validation, and verification activities including IQ/OQ/PQ validation, process capability studies, and equipment qualification. Lead root cause investigations and CAPA implementation. Monitor process performance and identify opportunities for yield improvement and cost reduction.
**Quality & Regulatory Compliance:** Ensure all manufacturing activities comply with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and GMP requirements. Collaborate with Quality Assurance on nonconformances, deviations, change controls, and audit findings. Support supplier qualification and ongoing quality management. Ensure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant.
**Cross-Functional Collaboration:** Work with R&D on product transitions from development to commercial manufacturing. Partner with Supply Chain and Planning on production schedules and demand planning. Support Regulatory Affairs with manufacturing documentation for submissions and inspections. Coordinate with Packaging, Sterilization, and Logistics teams.
**Operational Excellence:** Establish and monitor KPIs for manufacturing quality, throughput, scrap, and supplier performance. Drive continuous improvement using Lean, Six Sigma, or similar methodologies. Support scalable operational processes as the company grows. Assist in risk assessments related to manufacturing and supply continuity.
Note: This position requires working with hazardous drugs and PPE (gloves, respiratory protection, gown). Medical approval to wear respiratory protection is required. Physical exertion includes walking up to 50%, standing up to 100%, squatting/bending up to 20%, and lifting up to 50 lbs for up to 12-hour shifts. Candidates must confirm understanding of potential reproductive risks (teratogenicity, carcinogenicity, reproductive effects) from handling 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
