Lamination Engineer

2 weeks ago

Hyderabad, Telangana, India Sahajanand Medical Technologies Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Engineer Job Description-Lamination

  • Develop and Optimize Lamination 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

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