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Hims & Hers Health, Inc. is a health and wellness company that strives to innovate the industry with “a modern approach” and is on a mission to put an end t
Senior Program Manager, Devices
Location
United States
Posted
93 days ago
Salary
$130K - $160K / year
Seniority
Senior
Job Description
Senior Program Manager, Devices
Hims & Hers Health, Inc.
• 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. • 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. • 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.
Job 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
Benefits
- 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
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