2 - 5 years

6 - 11 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • 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


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Sahajanand Medical Technologies logo
Sahajanand Medical Technologies

Medical Devices

Mumbai

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