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 end-to-end from concept through commercialization, ensuring successful device development and regulatory clearance in a highly regulated environment.

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