Mechatronics Engineer

Location: Warsaw, IN 46580

Education: BE in Biomedical Engineering, Computer Science, Electronics Engineering, Mechanical Design, or a closely related field.

Experience: 4+ Years

Tata Elxsi works with leading OEMs and suppliers in the Automotive and Transportation industries for R&D, design, and product engineering services - right from architecture, to launch and beyond. We bring together technologies that accelerate the development & testing of connected, autonomous, and electric cars & off-highway vehicles. We are looking for a bright and passionate Mechatronics Engineer who can fulfill this position with good commitment!

Responsibilities & Duties:

1. Understanding the product and its manufacturing process (10%)
• Evaluating and evaluating part numbers for offshore regulatory actions (4%)
• Using Zimmer Biomet portals like Plotview and WOW to interpret the EU MDR SKU list (4%)
• Checking SharePoint's escalation tracker and query sheet daily. (2%)
  
  
2. Collecting Inputs, monitoring trackers, and submitting supplier-quality tech files. (37%)
• Evaluating the offshore team's tracker based on inputs from the master scope and other teams (Regulatory & Quality, PBL, internal manufacturing). (4%)
• Cross-checking the SKU tracker to the regulatory master scope. (3%)
• Providing the TEL offshore team with Zimmer Biomet ASL supplier contact data. Zimmer ASL suppliers: (5%)
1. Control Plan
2. Process Flow
3. Inspection Plan
4. PFMEA
5. Validation Documents
   
   
• Getting the updates from the TEL offshore team about the supplier contacts. If the supplier is not responding, reach out to the supplier to better understand the delay issue. (4%)
• Calling the supplier in case of EU MDR document queries. (2%)
• Assigning re-work when the quality of tech file is not proper. (2%)
• Constantly checking for scope updates and informing the offshore team about adding part numbers to their scope. (5%)
• Daily checking of the working tracker and evaluating the updates on the deliverables done by the TEL offshore team. (4%)
• Checking the Zimmer Biomet ZUDI SharePoint and Zimmer Biomet portal Livelink for previous documents of the current deliverables. (3%)
• Ask the TEL offshore team to provide the correct supplier tech file and check if they have followed the protocol of uploading it to the Zimmer Biomet ZUDI SharePoint. (2%)
  
  
3. Daily sync-up and Weekly status reporting (15%)
• Daily stand-up meetings with quality and regulatory SMEs to update delivery status and understand TEL offshore team challenges. (4%).
• Weekly status meetings with TEL offshore quality and regulatory, Zimmer onsite leads, and the core team to address project status, deliverables quality, challenges, and external and internal risks. (3%).
• Weekly meetings with TEL offshore to address escalations and question tracker. (3%)
• Assessing TEL offshore's presentations. (5%)
  
  
4. Coordinating with the Onsite and Offshore teams. (15%)
• Discuss deliverables with TEL offshore and Zimmer Biomet (4%)
• R&D, Clinical, Complaint Handling, Design Quality, and Manufacturing as needed (3%)
• Maintaining a smooth interaction between TEL and Zimmer, managing the TEL offshore team's progress, and ensuring it meets regulatory standards. (4%)
• Daily sync with TEL offshore team to understand their challenges (4%)
  
  
5. Project Deliverables Status Tracking (9%):
• Creating a tracker utilising Microsoft resources like Excel spreadsheets to monitor EU MDR project deliverables. (5%)
• TEL offshore team members meet weekly to discuss project status, questions, deliverable quality, and risks. (2%)
• Weekly team status reports specify milestones and follow MDR deadlines. (2%)
  
  
6. Process Improvements: (5%)
• Accessing the EU MDR delivery process and suggesting process improvements and optimization within the team. (1%)
• Reviewing deliverables' quality. (2%)
• Tracking flaws for each deliverable and taking corrective and preventive actions. (CAPA). (2%)
  
  
7. Handling IT issues for the TEL offshore team and providing access to the Zimmer Biomet tools as and when required. (2%)
8. Additional responsibilities as per the requirement (given by my supervisor). (3%)
9. Internal meetings with the senior leadership team for continuous improvements &
10. value-addition brainstorming. (2%)