Program Manager (Medical Device NPD)
Tata Elxsi · Posted Nov 4
Design and technology services, product engineering, systems integration, and digital transformation solutions
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About the role
Tata Elxsi’s Medical Device and Healthcare practice works with medical device OEMs and technology companies on market research, human factor engineering, hardware and software engineering, verification & validation, and regulatory compliance; the practice is ISO 13485 certified. The role leads end-to-end execution of a complex medical device New Product Development program spanning software, firmware, electrical hardware, mechanical design, cybersecurity, verification & validation, usability engineering, and regulatory compliance. The Program Manager coordinates global cross-functional teams and acts as the primary interface between client stakeholders, engineering teams, regulatory groups, quality teams, manufacturing partners, and executive leadership.
What you will do
- 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.
- 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.
Skills used in this role
What the employer is looking for
- Experience: 15+ Years Overall | 8+ Years in NPD Program Management
- 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
Benefits and support
- Compensation and benefits are detailed in the job posting
About Tata Elxsi
Tata Elxsi is a global provider of design-led technology services, specializing in product engineering, systems integration, and digital transformation. Operating across sectors like transportation, healthcare, and media, the company combines design thinking with advanced technologies such as AI, cloud, and IoT to help enterprises build connected, intelligent products.
- Industry
- Design Services
- Company size
- 11500+ employees
- Founded
- 1989
- Location
- Bengaluru, India
- Funding stage
- Public Company
Funding
Public Company · $0 raised
Leadership
Manoj Raghavan
CEO & Managing Director
Nalin Rana
Chief Financial Officer
Recent coverage
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