Senior Medical Device Sustainment Program Manager

Philips Iberica SAU; Cambridge, Northern (MA, KY); Hybrid; USD 136,000 - 216,000; Full time

Benefits offered by this job

Generous PTO

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Sr. Project Manager for Medical Devices to lead sustainment programs across hardware, SaMD, and connected platforms.

You will own end-to-end governance, manage schedules, risks, and reporting, and ensure products remain safe, compliant, and commercially viable throughout their lifecycle in a matrixed organization. You will collaborate with Quality, Regulatory, Clinical, and Post-Market Surveillance, applying ISO 14971 risk management and regulatory standards to drive

Qualifications

• 7+ years of software medical device product development and/or program management experience.
• Experience with sustenance or lifecycle management.
• Experience with SaMD and connected medical devices.
• Strong knowledge of medical device regulations and standards (ISO 13485, IEC 62304, ISO 14971).

Responsibilities

• Lead sustainment programs aligned to goals with end-to-end governance across planning, execution, and delivery.
• Manage program execution with integrated schedules, risk/issue tracking, and reporting to leadership.
• Own sustainment program management for a portfolio of medical devices including hardware, SaMD, and connected platforms.
• Drive roadmap clarity and execution for sustainment initiatives (enhancements, defect remediation, cybersecurity, regulatory changes).
• Implement and manage detailed program plans with timelines, resourcing, risk management, and dependencies.
• Partner with Quality, Regulatory, Clinical, and Post-Market Surveillance teams to monitor field performance and manage risk.
• Ensure regulatory and quality compliance across sustainment activities (FDA 21 CFR Part 820/QMSR, ISO 13485, IEC 62304, ISO 14971).
• Drive continuous improvement to reduce cycle time and improve reliability and customer experience.

Skills

Program management

Regulatory compliance

Cross-functional leadership

Education

Bachelor's/Master's in Business Administration or Project Management

Job description

Philips is seeking a Sr. Project Manager for Medical Devices to lead sustainment programs across hardware, SaMD, and connected platforms.

You will own end-to-end governance, manage schedules, risks, and reporting, and ensure products remain safe, compliant, and commercially viable throughout their lifecycle in a matrixed organization. You will collaborate with Quality, Regulatory, Clinical, and Post-Market Surveillance, applying ISO 14971 risk management and regulatory standards to drive