Senior Program Manager, Devices

Role Overview

• 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