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. The Senior Program Manager, Devices is responsible for managing medical device programs from concept through commercialization, leading cross-functional teams to ensure successful device development and regulatory clearance.

Responsibilities:

• 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
• 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
• 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
• 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

Requirements:

• 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
• Experience with sharps, lancets, phlebotomy, or diagnostic devices