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Hims & Hers, a publicly traded health and wellness platform, seeks 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.
Key responsibilities include:
**Contract Manufacturing Oversight**: Lead day-to-day manufacturing performance, quality metrics, and operational execution 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 during product development and design transfer. 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, and change controls. Support supplier qualification and audits. Ensure manufacturing documentation and Device History Records are complete and compliant.
**Cross-Functional Collaboration**: Work with R&D on product transitions from development to commercial manufacturing. Partner with Supply Chain on production schedules and inventory management. 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 or Six Sigma methodologies. Support scalable operational processes as the company grows.
Required qualifications: Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field). 8+ years of process engineering, operations engineering, or manufacturing engineering in medical device or diagnostics. Experience supporting Class II FDA-regulated medical devices in GMP environments. Direct CMO management or collaboration experience. Strong understanding of design controls, process validation, FDA Quality System Regulations, ISO 13485, CAPA and change control systems, and cross-functional collaboration in regulated environments.
