Program Manager (Sustaining)

Mass Digital Health; Cambridge (MA); On-site; USD 136,000 - 216,000; Full time

Benefits offered by this job

Annual incentive bonus

401k with up to 7% match

Education reimbursement

Generous PTO

Job summary

Mass Digital Health is seeking a Program Manager in Cambridge, MA, to lead sustainment programs for medical devices. You will be accountable for managing program execution rigor, ensuring regulatory compliance, and driving continuous improvement initiatives. Candidates should have over 7 years of experience in program management within the software medical device sector, along with a strong grasp of relevant regulations. The position offers a competitive salary range of $136,000 to $216,000 based on experience, with additional benefits including comprehensive health rewards, PTO, and 401k contributions.

Qualifications

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

Responsibilities

• Lead sustainment programs ensuring delivery within scope and budget.
• Manage program execution and track key performance indicators.
• Drive regulatory and quality compliance in all sustainment activities.

Skills

Program or Project Management

Medical Device Regulations

Post-Market Surveillance

Strong Communication

Education

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

Job description

Program Manager (Sustaining)

Job Description

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 have a bachelor's or master's Degree in Business Administration, Project Management or similar, or 9 + years of the above related experience.

  You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

• You are an excellent communicator and influencer, capable of aligning diverse stakeholders and driving decisions in a matrixed organization.

Benefits and Compensation

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. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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.