Program Manager (Medical Device NPD)

Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT.

Tata Elxsi's Medical Device and Healthcare practice is ISO 13485 certified.

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

Program Leadership & Delivery

• 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.
• Ensure alignment across multiple engineering workstreams.

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

• Medical device software development lifecycle
• Agile & Hybrid V-Model development

Firmware & Embedded Systems

• RTOS-based systems
• Device connectivity

Hardware Development

• Electronics product development lifecycle
• PCB development process

Verification & Validation

• Risk-based verification strategy

Cybersecurity

• Secure product development
• Threat modeling

Preferred Qualifications

• PMP Certification
• SAFe Agilist / Scrum Certification
• Systems Engineering Certification
• Medical Device domain experience in:
• Dialysis
• Infusion Systems
• Patient Monitoring
• Connected Medical Devices
• Renal Care Devices