Global Sustaining Hardware PM for Medical Devices

Jobtailor; Massachusetts; On-site; USD 140,000 - 180,000; Full time

Job summary

Jobtailor in the United States (Massachusetts) seeks an experienced Product Manager to own sustaining lifecycle plans for regulated medical devices, including MCT and Holter devices. Define business needs, clarify requirements, and drive changes through lifecycle and change-control processes.

You will coordinate cross-functional execution of product changes, manage critical issues with stakeholders, and partner with Quality and Regulatory on CAPA, post-market surveillance, and regulatory

Qualifications

• 5+ years in product management for regulated hardware or medical devices.
• Experience managing mature or sustaining hardware products and lifecycle planning.
• Experience in cardiology, ambulatory monitoring, connected devices, or wearables is a plus.
• Experience with medical device quality systems: design controls, risk management, CAPA, post-market surveillance, regulatory change assessment.
• Bachelor's degree in Engineering, Product Management, Business, Marketing, or related field.
• MBA or advanced degree preferred.
• US work authorization; sponsorship not offered.
• Must reside within commuting distance to Cambridge, MA or Malvern, PA.

Responsibilities

• Own the sustaining lifecycle plan and prioritized backlog for MCT and Holter devices.
• Lead product management activities for sustaining initiatives including requirements and acceptance criteria.
• Coordinate cross-functional changes (component/supplier changes, obsolescence remediation, labeling, IFU updates).
• Lead issue management with customers, field, service, quality, and operations; set priorities and draft containment plans.
• Partner with Quality and Regulatory on CAPA, risk management, and post-market surveillance.
• Monitor product health via complaints, reliability, service burden, and customer feedback.
• Support supply continuity, lifecycle transition, and end-of-life planning; coordinate regional impacts.
• Provide product expertise to Sales, Marketing, Service, Operations, and regional teams.

Skills

Lifecycle Planning

Product Changes

Issue Resolution

Risk Management

CAPA

Complaint Handling

Post-Market Surveillance

Design Controls

Product Performance Monitoring

Supply Chain Management

Education

Bachelor's degree in Engineering / related field

MBA or advanced degree preferred

Job description

Jobtailor in the United States (Massachusetts) seeks an experienced Product Manager to own sustaining lifecycle plans for regulated medical devices, including MCT and Holter devices. Define business needs, clarify requirements, and drive changes through lifecycle and change-control processes.

You will coordinate cross-functional execution of product changes, manage critical issues with stakeholders, and partner with Quality and Regulatory on CAPA, post-market surveillance, and regulatory