Sr. Project Manager (Medical Devices)

Philips; Cambridge (MA); Vor Ort; USD 95.000 - 130.000; Vollzeit

Zusammenfassung

A leading medical technology firm is looking for a Program Manager to oversee sustainment initiatives for its portfolio of medical devices. The ideal candidate will have over 7 years of experience in software medical device product development and strong knowledge of regulatory standards. Responsibilities include managing program execution, ensuring compliance, and driving continuous improvement initiatives. Candidates must be located near Cambridge, MA. This position offers the opportunity to work at the intersection of healthcare technology and compliance.

Qualifikationen

• 7+ years of software medical device product development experience.
• Hands-on experience with post-market surveillance and complaint handling.
• Strong knowledge of ISO 13485, IEC 62304, ISO 14971 regulations.

Aufgaben

• Lead structured sustainment programs aligned to organizational goals.
• Manage program execution rigor including schedules, risks, and issue tracking.
• Drive continuous improvement initiatives to enhance sustainment operations.

Kenntnisse

Program management

Medical device regulations

Stakeholder communication

Risk management

Ausbildung

Bachelor's or master's degree in Business Administration or Project Management

Jobbeschreibung

Responsibilities

• 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.

Qualifications

• 7+ years of software medical device product development and/or program or project management experience, with significant exposure to sustainment or lifecycle management.
• Your skills include:
  • 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 a related field, or 9+ years of qualifying experience.
• Excellent communicator and influencer, capable of aligning diverse stakeholders and driving decisions in a matrixed organization.
• Physical, cognitive, and environmental job requirements met.
• 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.