We are seeking an experienced Program Manager to lead end-to-end Medical Device Recent 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.
Robust expertise in program governance, stakeholder management, risk management, resource planning, and financial management.

Preferred Qualifications
PMP, Protected 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 Bengaluru
🏢 Tata Elxsi
📍 Bengaluru