Tata Elxsi brings together the best technology and user-centric design expertise to help customers deliver innovative solutions and great consumer experiences. Our integrated Design and Technology teams help enterprises reimagine their products and services – from strategy, consumer research and insights, to service and experience design, technology implementation, integration, launch, and beyond.
Discover opportunities to work with bright and passionate teams on challenging projects, learn and master the latest automotive software and digital technologies, and grow with us.
We are looking for
· Evaluate & analyze client’s medical devices for its function & application by screening Technical Documents (TD) from Agile PLM (1%)
· Analyze the manufacturing process documents and drawings for better understanding (2%)
· Perform a detailed analysis of manufacturing process steps and parts along with inspection procedures to study the product and its flow (2%)
- Design and Development (15%)
· Collaborate with engineers and specialists to design the overall system architecture (4%)
· Develop and test updated components required for the vision system using SolidWorks (5%)
· Create Design Control specifications as per the US FDA regulation 21 CFR 820.30 requirements (6%)
• User Requirement Specification (URS)
• Design Specification (DS)
• Trace Matrix (TM)
- Testing and Validation (30%)
· Develop comprehensive Process Validation activities including Master Validation Plan (MVP) to ensure the system meets all requirements as per US FDA regulation 21CFR part 820.75 requirements (5%)
· Perform rigorous testing of the automated system (12%)
• Installation Qualification (IQ)
• Operation Qualification (OQ)
• Performance Qualification (PQ)
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)
• Test Method Validation (TMV)
· Document test results and validation processes to ensure compliance with regulatory standards. (5%)
· Perform Data analysis of the tested samples by using MINITAB (statistical tool) (2%)
· Prepare detailed reports for process validation, test methods (6%)
- Risk Management (10%)
· Develop comprehensive risk management documents as per ISO 14971 standard (8%)
• Risk Management Plan (RMP)
• Process Failure Mode and Effects Analysis (PFMEA)
• Use Failure Mode and Effects Analysis (UFMEA)
• Risk Management Report (RMR)
· Identify potential risks and develop mitigation strategies to address them. (2%)
- Agile Change Management and Collaboration (18%)
· Create engineering change orders as per the US FDA regulation 21 CFR part 820 requirements in Medtronic Agile application (12%)
• Product/Process change (PCH)
• Quality Management System change (QCH)
• Record Change (RCH)
· Participate in regular team meetings to discuss progress of each change order, challenges, and next steps. (4%)
· Work closely with quality assurance, regulatory compliance, and production teams to ensure all aspects of the project are aligned (2%)
- Training and Support (4%)
· Train production and quality control staff on the new automated system and its operation. (2%)
· Offer ongoing support and troubleshooting for any issues that arise during the implementation and operation of the system. (2%)
- Periodic Technical Reviews and Client Approvals: (6%)
· Final Walkthrough of Tata Elxsi deliverables to expedite review and decisions with a client. (2%)
· Review the feedback received from Medtronic SME and cross-functional teams such as R&D, Quality, Regulatory, Design Quality, and Manufacturing incorporate those required changes, and finalize the documentation (2%)
· Prepare and submit query responses to offshore team members. (2%)
- Project Deliverables Status Tracking: (5%)
· Tracking of project deliverables within a defined timeline through the ‘Project tracker’ tool & Microsoft Project Plan (MPP) (2%)
· Weekly status report meeting with the client to define milestones & track project timelines (2%)
· Weekly status update to Operation Innovation project Manager and Lead for all deliverables as per plan (1%)
- Process Improvements: (4%)
· Provide suggestions for process improvement and explain regulations and procedures to the subordinates (2%)
· Track the defect density for each deliverable of products in Scope and take necessary Corrective and Preventive Actions. (CAPA) (2%)
- Internal meetings with senior leadership team for continuous improvements & value addition brainstorming (3%)
· Internal meetings with senior leadership team for continuous improvements & value addition brainstorming (2%)
· Correspond with clients to answer questions or resolve complaints. (1%)
Tata Elxsi offers a comprehensive compensation and benefits package. Tata Elxsi is an affirmative action-equal opportunity employer.
Tata Elxsi complies with all applicable federal, state and local laws regarding recruitment and hiring.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by applicable federal, state or local laws.
Tata Elxsi does not currently require partners or employees to be fully vaccinated or test negative for COVID-19 in order to go to Tata Elxsi offices, client sites or Tata Elxsi events, except when mandated by federal, state or local law.
In some circumstances, clients also may require proof of vaccination or testing (e.g., to go to the client site).
What are our perks for Full time employee?
We provide unique options to fit your unique lives!. Our menu of flexible options includes, but is not limited to:
• Excellent healthcare options: Medical, vision, prescription & dental
• Family Focus & Balance: medical, commuters & Dependant FSA, Competitive PTO, Sick Time, and Employee Assistance Program
• Financial Security: Competitive 401(k) match with Safe Harbor Plan,
• Employee Recognition Programs
• Perks AT works: Our exclusive one-stop online discount marketplace
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