Process Validation & Manufacturing

Tata Elxsi is among the world's leading providers of design and technology services across industries, including automotive, broadcast, communications, healthcare, and transportation. Tata Elxsi works with leading OEMs and suppliers in the automotive and transportation industries for R&D, design, and product engineering services from architecture to launch and beyond.

POSITION SUMMARY

We are seeking a highly motivated Design Transfer, Validation & DHF Engineer / Senior Engineer to support medical device product development, design transfer, manufacturing site transfer, process validation, and Design History File (DHF) management activities.

The role requires hands-on experience in design controls, process validation, manufacturing engineering, change management, and quality compliance. The selected candidate will collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, Manufacturing, Supplier Quality, and Operations to ensure products are developed, transferred, and maintained in compliance with global regulatory requirements and quality standards.

KEY OUTCOMES

· 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.

KEY RESPONSIBILITIES

Design Controls & DHF Management

· 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.

Process Validation & Manufacturing Support

· 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.

REQUIRED TECHNICAL COMPETENCIES

· 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

TOOLS & SYSTEMS

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

QUALIFICATIONS

Education

Bachelor's or master's degree in biomedical engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related discipline.

Experience

· Engineer: 3 to 6 years

· Senior Engineer: 6 to 10 years

Industry Experience

· Medical Devices

· Healthcare Products

· Regulated Product Development Environments

Preferred Experience

· Orthopedic devices

· Implants

· Surgical instruments

· Active medical devices

· DHF remediation programs

· Manufacturing transfer projects

· FDA and EU MDR compliance activities