Program Manager (Medical Device NPD)

Tata Elxsi; Pune District; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Tata Elxsi, Inc. in Pune seeks an experienced Program Manager to lead an end-to-end Medical Device New Product Development (NPD) program.

The role spans software, firmware, electrical hardware, mechanical design, cybersecurity, verification & validation, usability, and regulatory compliance. The ideal candidate will manage large-scale, regulated medical device programs from concept through commercialization, coordinating global teams and ensuring FDA, MDR, ISO 13485, IEC 62304, ISO 14971, IEC

Qualifications

• Experience leading large, regulated medical device NPD programs from concept to commercialization.
• Strong ability to coordinate global cross-functional teams across software, firmware, electrical hardware, mechanics and cybersecurity.
• Experience ensuring compliance with FDA, MDR, ISO 13485, IEC 62304, ISO 14971, IEC 62366 and related design controls.

Responsibilities

• Lead end-to-end NPD program execution from concept through product launch.
• Define and manage program scope, timelines, budget, risks, dependencies, and deliverables.
• Establish program governance, communication framework, and escalation mechanisms.
• Drive phase gate reviews and ensure successful completion of all program milestones.
• Track program progress against schedules, KPIs, and quality objectives.

Job description

Program Manager – New Product Development (NPD)

Domain: Medical Devices (Peritoneal Dialysis / Renal Care / Connected Medical Devices)

Experience: 15+ Years Overall | 8+ Years in NPD Program Management

Location: Pune

Job Summary

We are seeking an experienced Program Manager to lead end-to-end execution of a complex Medical Device New Product Development (NPD) Program involving Software, Firmware, Electrical Hardware, Mechanical Design, Cybersecurity, Verification & Validation, Usability Engineering, and Regulatory Compliance.

The ideal candidate should possess strong expertise in managing large-scale regulated medical device programs from concept through commercialization, while coordinating global cross‑functional teams and ensuring compliance with FDA, MDR, ISO 13485, IEC 62304, ISO 14971, IEC 62366, and cybersecurity requirements.

This role will act as the primary interface between client stakeholders, engineering teams, regulatory groups, quality teams, manufacturing partners, and executive leadership.

Key Responsibilities

• Lead end-to-end NPD program execution from concept through product launch.
• Define and manage program scope, timelines, budget, risks, dependencies, and deliverables.
• Establish program governance, communication framework, and escalation mechanisms.
• Drive phase gate reviews and ensure successful completion of all program milestones.
• Track program progress against schedules, KPIs, and quality objectives.

Design Controls & Compliance

• Ensure compliance with:
• ISO 13485, IEC 62304, ISO 14971, IEC 60601 Series, IEC 62366, IEC 81001
• FDA Design Controls, MDR Requirements
• Monitor Design Input, Design Output, Verification, Validation, and Design Transfer activities.
• Ensure proper DHF, DMR, and technical documentation management.

Technical Expectations

Candidate should possess solid understanding of:

Software Development

Firmware & Embedded Systems

• RTOS-based systems
• Device connectivity

Hardware Development