Program Manager (Sustaining)

Philips Iberica SAU; Northern (KY); Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

A leading medical technology company is searching for a Program Manager (Sustaining) based in Cambridge, MA. In this role, you will lead the sustainment programs of medical devices, ensuring compliance and quality while managing cross-functional teams. The ideal candidate will have over 7 years of experience in software medical device product development and demonstrate strong communication skills to manage diverse stakeholders. Knowledge of medical device regulations such as ISO 13485 and IEC 62304 is essential. US work authorization is required, and relocation benefits will not be provided.

Qualifikationen

• 7+ years of experience in software medical device product development or program/project management.
• Hands-on experience managing in-market products and their sustenance.
• Strong knowledge of medical device regulations and standards.

Aufgaben

• Lead sustainment programs ensuring delivery within scope, schedule, and budgets.
• Manage program execution with rigor across multiple projects.
• Ensuring regulatory compliance across all sustainment activities.

Kenntnisse

Software medical device product development

Program or project management

Post-market surveillance

Complaint handling/CAPA

Medical device regulations (ISO 13485, IEC 62304, ISO 14971)

Communication and influencing skills

Jobbeschreibung

Program Manager (Sustaining)

Your 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.

You're the right fit if:

• You’ve acquired 7+ years of software medical device product development and/or program or project management experience, with significant exposure to sustenance or lifecycle management.
• Your skills include:
  • Hands‑on experience managing products in‑market including post‑market surveillance, complaint handling/CAPA and sustenance 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.
• You are an excellent communicator and influencer, capable of aligning diverse stakeholders and driving decisions in a matrixed organization.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Malvern, PA or Cambridge, MA.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.