Global Product Manager – Sustaining Hardware

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

• 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

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.

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

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

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

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