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.
- Robust 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) (Pune)
🏢 Tata Elxsi
📍 Pune