Braiding Engineer

Engineer Job Description-Braiding

• Develop and Optimize Braiding Parameters for new Catheter Designs
• Conduct DOE and Data based optimization to improve process performance
• Define and Establish Process Windows and ensure scalability from prototype to commercial production
• Lead Machine Installation, Setup and Qualification(IQ/OQ/PQ)
• Develop and Execute Validation Protocols and reports per QMS requirements
• Support Maintenance and Calibration in collaboration with Maintenance and Quality teams
• Provide day-to-day technical support to Production related issues
• Troubleshoot Process Deviations, Cosmetic Defects and Mechanical Property Variations
• Conduct Root Cause Analysis(RCA) and implement Corrective and Preventive Actions(CAPA)
• Prepare and Maintain Process Documentation: SOPs, Work Instructions, Process Specifications, DHR templates
• Good to have experience from regulated fields like Medical device, Pharma etc
• Knowledge on ISO standards like 13485,14971 etc
• Participate in Internal and External Audits
• Monitor and Analyze Process Capability Indices(Cp, Cpk) etc
• MTech/BTech from Mech, Biomedical, Metallurgy or other similar fields can apply
• Experienced Needed. Fresher can apply