Senior Program Manager, Devices at Hims And Hers

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 [Upgrade to PRO to see link] and hims.com/how-it-works [Upgrade to PRO to see link] . 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 [Upgrade to PRO to see link] 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 studies. - Work with Design Assurance to track design milestones including design inputs/outputs, verification, validation, and design reviews. MANUFACTURING & SUPPLY CHAIN - Support design transfer activities, manufacturing readiness assessments, process validations, and supplier qualifications for medical device production. - Support vendor and contract manufacturer partnerships related to device development, testing, sterilization, packaging, and production. - Support design transfer, manufacturing readiness, and product launch activities. STAKEHOLDER COMMUNICATION & DOCUMENTATION - Schedule and lead cross-functional meetings, design reviews, risk management sessions, and milestone reviews, maintaining organized documentation and meeting summaries. - Develop high-quality documentation and presentations that clearly communicate complex technical and regulatory information, demonstrate strategic insight, and convey a confident executive presence when engaging with senior leadership. - Provide clear and concise project status updates to leadership and stakeholders. - Partner with R&D, Engineering, Quality, Regulatory Affairs, Clinical, Supply Chain, and Commercial teams to drive device development, verification and validation, regulatory submissions, and launch readiness. YOU HAVE: - Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Life Sciences, or related technical field. - 8+ years of program/project management experience in medical device development from concept through commercialization. - Demonstrated experience managing Class II medical device development programs through FDA 510(k) clearance. - Direct familiarity with planning, executing, and supporting biocompatibility testing), sterilization validation, packaging validation, and shelf life and accelerated aging studies. - Experience managing medical device programs through key milestones including design freeze, verification/validation, design transfer, regulatory submission, and commercial launch. - Understanding of manufacturing processes for medical devices including sterilization, packaging, labeling, and quality control. - Proven ability to lead cross-functional teams in a regulated environment. - Excellent organizational, communication, and stakeholder management skills with the ability to translate complex technical and regulatory concepts for diverse audiences. - Experience operating within product-driven organizations with many stakeholders and fast-moving programs. - Extreme attention to detail and documentation, particularly for design history files, regulatory submissions, and compliance requirements. - Strong leadership and relationship-building skills with an ability to quickly make decisions while remaining objective. - Can-do, positive attitude that enjoys managing multiple projects and tasks simultaneously. - Curious and collaborative mindset with the ability to foster teamwork at all levels of the organization. - 25% Travel OUR BENEFITS (THERE ARE MORE BUT HERE ARE SOME HIGHLIGHTS): - Competitive salary & equity compensation for full-time roles - Unlimited PTO, company holidays, and quarterly mental health days - Comprehensive health benefits including medical, dental & vision, and parental leave - Employee Stock Purchase Program (ESPP) - 401k benefits with employer matching contribution - Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [Upgrade to PRO to see contact] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement [Upgrade to PRO to see link]