Top Quality Manufacturing Specialist

7 days ago

Amrāvati, Maharashtra, India beBeeManufacturing Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Role:

We are seeking a highly skilled Senior Manufacturing Engineer to join our team at Horizontal Talent. The successful candidate will be responsible for ensuring the manufacturability, accuracy, and completeness of engineering drawings, as well as applying knowledge of medical device regulations to execute gap assessments and remediation activities.


Key Responsibilities:

  • Review and validate engineering drawings for manufacturability, accuracy, and completeness as per the latest engineering standards.
  • Apply knowledge of medical device regulations to execute gap assessments, manufacturing print reviews, and remediation activities.
  • Participate in ideation activities to assess project scoping and viability through economic analysis, conflict analysis, and supplier quote validation.
  • Conduct, review, and update models for tol-stackup studies and dimensional variation analysis (1D/2D) using Creo-CETol or other tools.
  • Apply project management skills to plan, schedule, and monitor project activities efficiently ensuring FTR & OTD excellence.
  • Collaborate with global stakeholders across regions like category managers, sourcing, PM, and other cross-functional teams as per the project needs.
  • Review and validate PPAP reports received from suppliers and assess if the technical specifications are met.
  • Develop and refine detailed 2D drawings and 3D CAD models to support project requirements.
  • Design Remediation (Engineering Specification Gap Assessment).
  • Assist in developing Master Validation Plans, including process flow, OQ, and PQ.
  • Perform CPK (Process Capability Index) and ANOVA (Analysis of Variance) studies.

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