Job Description Summary
Job Description
Senior VERIFICATION ENGINEER
We are seeking qualified seniorverification engineer to lead the verification strategy creation and execution to deliver high-volume single use disposable medical products. This dynamic role will have you working with cross-functional engineering teams to guide products through verification using BD’s Stage Gate framework, DFM/DFSS to deliver cost-effective design-transfer.Key Responsibilities

  • Participate in all phases of new product development to understand design intent, intended uses and relevant regulatory standards.
  • Lead creation and execution of verification protocols, summarize results, enable formal design reviews and own the verification portion of the Design History File.
  • Ensure various tools, gauges, measurement system are under-calibration and proactively highlight those that need calibration.
  • Interpret and analyze design verification data with respect to product performance and operational stability in the manufacturing plants.
  • Ability to use Six-Sigma, DMAIC tool-kit and statistical analyses with descriptive statistics.
  • Demonstrate proficiency in spotting Design Variance through relevant statistical measures.
  • Follow Design Control & ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.

Skills and Requirement

  • Bachelor’s Degree in Mechanical, Industrial & Production, Bio-medical, Chemical, Materials Engineering, or Instrumentation

·Minimum 6 years of performing design & verification testing, including creation/execution of test protocols and procedure, performing data analyses in Medical Devices, Pharmaceuticals, Petrochemicals, Aerospace, Automotive industries will be preferred.
·Exposure MINITAB, STATISTICA, R and other Statistical software.
·Experience in fixture development, test-method development using CAD/CAM Software.

  • Proven experience in leading CAPAs, design-defect analyses, remediation is required.

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