We are seeking an experienced Program Manager to lead end-to-end Medical Device New Product Development (NPD) programs from concept through commercialization. The role involves managing global, cross-functional teams across Software, Firmware, Hardware, Mechanical Engineering, V&V, Cybersecurity, Quality, and Regulatory functions, ensuring timely delivery and compliance with medical device standards.

Key Responsibilities

• Lead end-to-end medical device product development programs, managing scope, timelines, budgets, resources, risks, and deliverables.

• Establish program governance, track milestones, drive phase-gate reviews, and manage stakeholder communication.

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

• Manage the complete product development lifecycle, including design controls, development, verification, validation, design transfer, and product release.

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

• Oversee design documentation, risk management, change control, testing, and regulatory deliverables.

• Manage resource planning, budget tracking, vendor coordination, and global team dependencies.

• Act as the primary point of contact for client stakeholders, engineering teams, manufacturing partners, and executive leadership.

Required Skills & Qualifications

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

• Minimum 5 years of experience managing regulated Medical Device NPD programs.

• Proven experience leading programs involving Software, Firmware, Electrical/Mechanical Hardware, V&V, and Cybersecurity.

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

• Knowledge of embedded systems, firmware, electronics development, software architecture, verification, and validation processes.

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

• Strong 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.

Program Manager (Medical Device NPD)