Sr. Project Manager (Medical Devices)

About the role

Leading structured sustainment programs aligned to organizational goals, ensuring delivery within defined scope, schedule, and budget constraints. Providing end-to-end governance across planning, execution, and delivery with limited supervision and strong ownership. Managing program execution rigor, including integrated schedules, dependencies, risks, and issue tracking, clear escalation pathways and decision-making forums. Providing transparent reporting to leadership on scope, timelines, quality, and compliance.

Owning the sustainment program management for a portfolio of medical devices, including hardware, Software as a Medical Device (SaMD), and connected digital platforms. Ensuring products in the field remain safe, effective, compliant, and commercially viable throughout the full lifecycle.

Driving the roadmap clarity and execution for sustainment initiatives such as minor enhancements, defect remediation, cybersecurity updates, and regulatory-driven changes. Balancing speed, quality, and compliance to support revenue continuity and customer satisfaction.

Implementing and managing detailed program plans covering timelines, resourcing, risk management, and cross-functional dependencies. Monitoring performance using KPIs such as schedule and cost variance, proactively identifying and mitigating risks to keep programs on track.

Partnering cross-functionally with Quality, Regulatory, Clinical, and Post‑Market Surveillance teams to monitor field performance and manage risk. Applying structured risk assessment practices (e.g., ISO 14971) to proactively identify issues and ensure timely, compliant remediation.

Ensuring regulatory and quality compliance across all sustainment activities, including adherence to FDA 21 CFR Part 820/QMSR, ISO 13485, IEC 62304, ISO 14971 and cybersecurity and data privacy requirements (as applicable).

Driving continuous improvement initiatives to enhance efficiency of sustainment operations, reduce cycle time, and improve product reliability and customer experience. Enabling data-driven decision making by defining and tracking key KPIs.

Responsibilities

• Lead structured sustainment programs aligned to organizational goals.
• Ensure delivery within defined scope, schedule, and budget constraints.
• Provide end-to-end governance across planning, execution, and delivery.
• Manage program execution rigor, including integrated schedules, dependencies, risks, and issue tracking.
• Establish clear escalation pathways and decision-making forums.
• Provide transparent reporting to leadership on scope, timelines, quality, and compliance.
• Own sustainment program management for a portfolio of medical devices, including hardware, SaMD, and connected digital platforms.
• Ensure products in the field remain safe, effective, compliant, and commercially viable throughout the full lifecycle.
• Drive roadmap clarity and execution for sustainment initiatives such as minor enhancements, defect remediation, cybersecurity updates, and regulatory-driven changes.
• Balance speed, quality, and compliance to support revenue continuity and customer satisfaction.
• Implement and manage detailed program plans covering timelines, resourcing, risk management, and cross-functional dependencies.
• Monitor performance using KPIs such as schedule and cost variance.
• Proactively identify and mitigate risks to keep programs on track.
• Partner cross-functionally with Quality, Regulatory, Clinical, and Post‑Market Surveillance teams.
• Apply structured risk assessment practices (e.g., ISO 14971) to proactively identify issues and ensure timely, compliant remediation.
• Ensure regulatory and quality compliance across all sustainment activities.
• Drive continuous improvement initiatives to enhance efficiency of sustainment operations.
• Enable data-driven decision making by defining and tracking key KPIs.

Requirements

• 7+ years of software medical device product development and/or program or project management experience, with significant exposure to sustainment or lifecycle management.
• Hands-on experience managing products in-market including post-market surveillance, complaint handling/CAPA and sustainment releases (patches, updates, minor features).
• Strong knowledge of medical device regulations and standards including ISO 13485, IEC 62304, ISO 14971.
• Experience with SaMD and/or connected medical devices is highly preferred.
• Bachelor's or master's degree in Business Administration, Project Management or similar, or 9+ years of related experience.

Skills

• Excellent communicator and influencer, capable of aligning diverse stakeholders and driving decisions in a matrixed organization.

Benefits

• Comprehensive Philips Total Rewards benefits program, including generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, and education reimbursement.

Pay

The pay range for this position in PA is $127,000 to $202,000. The pay range for this position in MA is $136,000 to $216,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.