Description
Hims & Hers is hiring a Senior Process / Operations Engineer – Regulated Devices to oversee contract manufacturing operations for a Class II FDA-regulated medical device used for capillary blood collection. The role serves as the primary technical operations lead for external CMOs and critical suppliers, managing manufacturing performance, quality, regulatory compliance, process validation, CAPAs, supplier audits, and continuous improvement while collaborating with R&D, Quality, Regulatory Affairs, Supply Chain, and other cross-functional teams. The position requires a bachelor’s degree in engineering and at least eight years of relevant experience in medical device process or manufacturing engineering, with experience in GMP environments and CMO management.
