Global Product Manager – Sustaining Hardware

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

Own the sustaining lifecycle plan and prioritized backlog for MCT and Holter devices
Lead product management activities for sustaining initiatives, including defining business and user needs, clarifying requirements and acceptance criteria, assessing impacts, and driving decisions through lifecycle and change-control processes
Coordinate cross-functional execution of product changes, including component or supplier changes, obsolescence remediation, manufacturing and service process changes, labeling, packaging, IFU updates, reliability improvements, and cost-reduction initiatives
Lead customer, field, service, quality, and operational issue management; assess impact, establish priorities, align stakeholders on containment and resolution, and support communications
Partner with Quality and Regulatory on complaint trends, CAPA, risk management, post-market surveillance, audits, and regulatory documentation
Monitor product health using complaints, returns, reliability, service burden, supply availability, cost, and customer feedback
Identify trends and drive corrective or improvement actions
Support supply continuity, lifecycle transition, and end-of-life planning, including demand, inventory, component availability, regional impacts, customer transitions, and next-generation sensor alignment
Provide product expertise to Sales, Marketing, Service, Operations, and regional teams
Maintain product documentation, roadmap and status, and stakeholder alignment
Escalate risks and trade-offs with clear recommendations

Requirements

• 5+ years of experience in product management, including responsibility for regulated hardware or medical devices, required
• Experience managing mature or sustaining hardware products, including lifecycle planning, product changes, issue resolution, product performance, and continuity
• Experience in cardiology, ambulatory monitoring, connected devices, wearable sensors, manufacturing or supply chain, or service operations is a plus
• Experience with medical device quality systems and regulated product processes, including design controls, risk management, CAPA, complaint handling, post-market surveillance, and regulatory change assessment
• Bachelor's degree in Engineering, Product Management, Business, Marketing, or a related field, required
• MBA or advanced degree is preferred
• Ability to perform minimum physical, cognitive, and environmental job requirements with or without accommodation
• Ability to travel to customer and company sites domestically and internationally; travel not expected to exceed 10–20%
• US work authorization required; candidates requiring sponsorship now or in the future will not be considered
• Must reside in or within commuting distance to Cambridge, MA or Malvern, PA

Core Competencies

Demonstrates expertise in product management for regulated hardware, particularly in the medical device sector, with a focus on lifecycle planning, quality systems, and cross-functional collaboration. Proven ability to drive product changes, manage customer and operational issues, and ensure compliance with regulatory standards.

Highest-signal resume keywords

• Product Management
• Lifecycle Planning
• Medical Device Quality Systems
• Regulatory Compliance
• Cross-Functional Coordination

Hard Skills

• Lifecycle Planning
• Product Changes
• Issue Resolution
• Risk Management
• CAPA
• Complaint Handling
• Post-Market Surveillance
• Design Controls
• Product Performance Monitoring
• Supply Chain Management

Soft Skills

• Stakeholder Alignment
• Communication
• Problem-Solving
• Prioritization
• Team Collaboration

Industry Keywords

• Medical Devices
• Cardiology
• Ambulatory Monitoring
• Connected Devices
• Wearable Sensors
• Manufacturing
• Service Operations
• Regulatory Documentation
• Quality Systems
• Obsolescence Remediation