Program Manager (Medical Device NPD)

We are looking for a seasoned Program Manager to oversee end-to-end Medical Device New Product Development (NPD) initiatives, taking products from early concept through successful commercialization. This position requires leading global, cross-functional teams spanning Software, Firmware, Hardware, Mechanical Engineering, V&V, Cybersecurity, Quality, and Regulatory functions, while ensuring on-time execution and adherence to medical device standards.

Key Responsibilities

• Lead end-to-end medical device product development programs by managing scope, schedules, budgets, staffing, risks, and all program deliverables.

• Define and implement program governance, monitor milestone progress, facilitate phase-gate reviews, and manage communications across key stakeholders.

• Coordinate cross-functional engineering teams across software, firmware, hardware, mechanical design, V&V, cybersecurity, and regulatory workstreams.

• Direct the full product development lifecycle, including design controls, development activities, verification, validation, design transfer, and product release.

• Maintain compliance with FDA, MDR, ISO 13485, IEC 62304, ISO 14971, IEC 60601, and other relevant medical device standards.

• Supervise design documentation, risk management activities, change control processes, testing execution, and preparation of regulatory deliverables.

• Lead resource planning, budget tracking, vendor coordination, and management of global team dependencies.

• Serve as the primary interface for client stakeholders, engineering teams, manufacturing partners, and executive leadership.

Required Skills & Qualifications

• 15+ years of overall engineering experience, including 8+ years in Program Management.

• At least 5 years of experience leading regulated Medical Device NPD programs.

• Demonstrated experience delivering programs that include Software, Firmware, Electrical/Mechanical Hardware, V&V, and Cybersecurity components.

• Strong knowledge of the medical device product development lifecycle, design controls, systems engineering, and regulatory compliance requirements.

• Familiarity with embedded systems, firmware, electronics development, software architecture, and verification and validation practices.

• Experience managing global cross-functional teams, OEMs, and contract manufacturers.

• Deep expertise in program governance, stakeholder management, risk management, resource planning, and financial management.

Preferred Qualifications

• PMP, SAFe Agilist, or Scrum certification.

• Experience in Dialysis, Infusion Systems, Patient Monitoring, Connected Medical Devices, or Renal Care Devices.

• Exposure to medical device cybersecurity, cloud-connected devices, and regulatory submissions.