Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role

The Senior Process / Operations Engineer – Regulated Devices is responsible for overseeing contract manufacturing operations for a Class II FDA-regulated medical device used for capillary blood collection from a patient’s upper arm into a collection tube for laboratory diagnostic analysis.

This role serves 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. The senior engineer will work cross-functionally with R&D, Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support product commercialization, process scalability, validation, and continuous improvement initiatives.

The ideal candidate has strong experience in medical device process engineering, supplier/CMO management, and regulated manufacturing environments with a deep understanding of FDA and ISO quality system requirements.

You Will

Contract Manufacturing Oversight

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

Ensure manufacturing processes consistently meet product specifications, quality standards, and production targets

Drive accountability with manufacturing partners regarding timelines, deviations, CAPAs, and continuous improvement initiatives

Process Engineering & Manufacturing Support

Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables

Partner with R&D during product development and design transfer activities to ensure manufacturability and scalability

Support process characterization, validation, and verification activities, including: o IQ/OQ/PQ validation

Process capability studies

Equipment qualification

Manufacturing line readiness

Lead root cause investigations and implementation of corrective and preventive actions (CAPAs) related to manufacturing or process issues

Monitor process performance and identify opportunities for yield improvement, cost reduction, and operational efficiency

Quality & Regulatory Compliance

Ensure all manufacturing activities comply with:

FDA Quality System Regulations (21 CFR Part 820)

ISO 13485

GMP requirements

Internal quality system procedures

Collaborate closely with Quality Assurance to address nonconformances, deviations, change controls, and audit findings

Support supplier qualification, supplier audits, and ongoing supplier quality management activities

Ensure manufacturing documentation, Device History Records (DHRs), and validation records are complete and compliant

Cross-Functional Collaboration

Work closely with R&D teams to transition new products from development into commercial manufacturing

Partner with Supply Chain and Planning teams to support production schedules, inventory management, and demand planning

Support Regulatory Affairs with manufacturing-related documentation for regulatory submissions and inspections

Coordinate with Packaging, Sterilization, and Logistics teams to ensure seamless product release and shipment readiness