Senior Program Manager, Devices

Senior Program Manager, Devices 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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE: The Senior Program Manager, Devices sits on the PMO team, reporting to the PMO Director, and is responsible for managing medical device programs end-to-end from concept through commercialization. This role leads cross-functional execution for the development and regulatory clearance of Class II medical devices through the FDA 510(k) pathway, with a current focus on an innovative blood collection technology designed to simplify the blood draw experience while delivering clinically reliable samples for laboratory analysis. This role partners closely with R&D, Engineering, Creative, Quality, Regulatory Affairs, Supply Chain, Operations, Clinical, and Commercial teams to ensure successful device development, regulatory clearance, and market launch. You will not just track timelines—you will own program clarity, decision-making rhythms, and execution discipline in a highly regulated, fast-moving environment. The role requires exceptional program management skills, deep knowledge of medical device development processes, FDA regulatory pathways, and design controls, along with the ability to lead cross-functional teams through ambiguity. Experience with sharps, lancets, phlebotomy, or diagnostic devices is preferred. YOU WILL: PROGRAM LEADERSHIP & EXECUTION - Manage medical device programs end-to-end from concept through commercialization, ensuring deliverables are met on time, risks are anticipated and mitigated, and stakeholders are kept informed. - Own integrated project plans, timelines, budgets, and risk management activities across all program phases. - Coordinate cross-functional teams to ensure alignment on timelines, resource requirements, dependencies, and critical path activities throughout the device development lifecycle. - Track critical path activities across engineering, regulatory, clinical, and commercial workstreams, proactively identifying risks or delays and driving resolution. - Show agility by adapting programs as they develop and change in order to meet the technical, regulatory, and commercial challenges inherent in medical device innovation. - Drive continuous improvement efforts by recommending enhancements to device development processes, design control systems, and cross-functional collaboration. REGULATORY & QUALITY COMPLIANCE - Lead cross-functional development programs for Class II medical devices from concept through FDA 510(k) clearance and commercialization. - Own integrated project plans, timelines, budgets, and risk management activities. - Drive execution across R&D, Quality, Regulatory, Manufacturing, Clinical, and Supply Chain teams. - Partner closely with Regulatory Affairs to support 510(k) strategy, submission development, and FDA interactions. - Work with R&D to plan, track, and coordinate required testing and validation activities, including biocompatibility testing (ISO 10993), sterilization validation, packaging validation, and shelf life and aging st ... (truncated, view full listing at source)