Process Validation & Manufacturing
Tata Elxsi · Posted Oct 8
Design and technology services, product engineering, systems integration, and digital transformation solutions
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About the role
Tata Elxsi is a design and technology services provider across automotive, broadcast, communications, healthcare, and transportation, working with leading OEMs and suppliers on R&D, design, and product engineering from architecture to launch and beyond. This role supports medical device product development, design transfer, manufacturing site transfer, process validation, and Design History File (DHF) management within regulated product development environments. The selected candidate collaborates with R&D, Quality, Regulatory Affairs, Manufacturing, Supplier Quality, and Operations to ensure products comply with global regulatory requirements and quality standards.
What you will do
- Deliver complete, accurate, and inspection-ready DHF documentation.
- Support successful design transfer and manufacturing site transfer projects.
- Execute process validation and equipment qualification activities in compliance with quality requirements.
- Ensure end-to-end traceability across design controls, risk management, verification, validation, and manufacturing records.
- Support regulatory inspections, audits, and compliance initiatives.
- Create, review, and maintain Design History File (DHF) documentation throughout the product lifecycle.
- Establish and maintain traceability between user needs, design inputs, design outputs, risk controls, verification, validation, and design transfer activities.
- Support design reviews and ensure design control documentation is complete and compliant.
- Develop and maintain traceability matrices and DHF records.
- Execute process validation activities including IQ, OQ, and PQ protocols.
- Support equipment qualification and manufacturing process characterization activities.
- Participate in manufacturing site transfer and technology transfer projects.
- Support implementation and optimization of manufacturing processes.
- Analyze process performance and support continuous improvement initiatives.
Skills used in this role
What the employer is looking for
- Design Controls
- DHF Management
- Process Validation (IQ/OQ/PQ)
- Equipment Qualification
- Design Transfer
- Manufacturing Site Transfer
- Technology Transfer
- Risk Management (ISO 14971)
- Verification & Validation
- Change Control (ECR/ECN)
- CAPA & Nonconformance Management
- Root Cause Analysis
- Bachelor's or master’s degree in biomedical engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related discipline.
- Experience — Engineer: 3 to 6 years
- Experience — Senior Engineer: 6 to 10 years
- Industry Experience — Medical Devices
- Industry Experience — Healthcare Products
- Industry Experience — Regulated Product Development Environments
Preferred qualifications
- Experience with one or more of the following is preferred: PTC Windchill/Agile PLM
- Vault or equivalent DHF Management Tools
- Document Management Systems
- Microsoft Office Suite incl. Advanced Excel
- Orthopedic devices
- Implants
- Surgical instruments
- Active medical devices
- DHF remediation programs
- Manufacturing transfer projects
- FDA and EU MDR compliance activities
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
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