Senior Program Manager, Devices
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Program Manager managing end-to-end medical device programs at Hims & Hers. Collaborating with cross-functional teams to drive innovation in health and wellness technology.
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.
- 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.
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
Similar Jobs
Program Manager, Internal and Patient Communications
Program Manager for Internal and Patient Communications at City of Hope managing communication strategies. Collaborating with clinical and administrative teams to enhance patient care experience and engagement.
Senior Program Analyst
Senior Program Analyst supporting the VA Office of Research and Development. This role involves program coordination and operational analysis for field-based research initiatives.
Program Analyst – Skillbridge Internship
Program Analyst supporting project management within NSTXL's Skillbridge Internship Program. Responsible for data analysis, meeting coordination, and reporting on project milestones and risks.
Junior Automotive Program Manager
Program Manager for complex automotive programs ensuring execution from concept to launch. Overseeing quality, cost, and strategic objectives within the Driveline/Transmission systems family.
Social Impact Program Manager, Enterprise Accounts
Social Impact Program Manager coordinating large-scale volunteer experiences for enterprise clients through effective account management and event logistics.
Health Equity Program Management Advisor
Program Management Advisor leading the Enterprise Health Equity and Language Accessibility Program at Cigna. Blend strategy, execution, and collaboration to improve patient outcomes and reduce health disparities.
Senior Program Manager
Program Manager overseeing complex cross-platform projects at Network Solutions. Responsible for strategic planning, execution, and stakeholder communication within diverse teams.
Senior Enterprise Program Manager
Enterprise Program Manager for Esri managing global enterprise customer strategy and execution. Collaborating with cross-functional teams to drive measurable business outcomes in multiple sectors.
Palliative Care Education – Student Affairs and Recruitment Program Manager
Lead daily operations and administration for Palliative Care Education Programs at CU Anschutz. Responsibilities include admissions, student advising, and managing marketing strategies.
Senior Program Management Analyst – RN
Senior Analyst managing clinical and operational programs utilizing nursing expertise in collaboration with external partners. Focused on program effectiveness and continuous improvement aligned with organizational objectives.
Palliative Care Education – Student Affairs and Recruitment Program Manager
Program Manager overseeing Palliative Care Education Programs at CU Anschutz. Leading operations, student affairs, and recruitment in an online environment.
Program Manager
Program Manager responsible for managing strategic programs and coordinating between teams at Bluehost. Ensuring project delivery through structured communication and proactive tracking.
Director, Program Management – Strategic Initiatives
Director of Program Management overseeing strategic initiatives at Bluehost, ensuring execution across cross-functional teams and managing a team of program managers.
Program Manager – Integrated Service Strategy
Program Manager for Digible managing cross-functional initiatives in digital marketing strategy execution. Collaborating across teams to enhance integrated services and channel coordination.
Medicare Stars & Quality Program Analyst
Analyst supporting Capital Medicare Advantage Star Ratings Program analytics. Focused on improving or maintaining Medicare stars ratings through data-driven strategies and reporting.
Senior Program Management Advisor – Payment Integrity
Program Management Senior Advisor responsible for project execution and governance at Cigna. Ensuring alignment with scope, budget, and quality for successful project delivery in healthcare.
Program Manager – AI Agency
Program Manager leading AI-driven marketing projects in the healthcare industry. Responsible for project execution, team coordination, and budget management in a fast-paced environment.
Senior Lead Customer Project / Program Manager, Manheim Digital
Sr Lead Customer Project/Program Manager at Cox Automotive focusing on strategic and tactical guidance for clients. Transforming vehicle portfolio management in a remote role.
Governance, Risk & Control Program Manager – AI
Governance, Risk & Control Program Manager for AI at Trissential leading enterprise-wide AI governance initiatives. Manage high-impact projects shaping AI governance strategy and execution.
Program Manager III
Program Manager leading mission-critical operational support for public health emergencies at SOSi. Responsible for planning, coordination, and execution during disasters and federal response operations.