How will you make an impact?

  • Lead and mentor a team of Quality Engineers, Test Engineers and Technicians to build comprehensive test suites to verify functionality of breakthrough medical products
  • Partner with Project Managers, System Engineers, and other technical leads to plan and execute on project goals
  • Develop robust risk management plans, test plans, strategies, and reports
  • Help define product requirements to ensure products are complete and testable
  • Assess test impacts for design changes and approve design changes
  • Ensure manufacturing quality for engineering, verification and clinical trial builds
  • Participate and contribute towards Regulatory and Agency submissions
  • Facilitate design control compliance, design transfer plans and sustaining engineering quality support

To be successful in this role, you will need the following skills and experience:

  • BS degree in Physics, Electrical, Mechanical, and/or Biomedical Engineering
  • Minimum 7 years of Quality/Test Engineering experience in an R&D environment for an electrical-mechanical device (medical preferred)
  • The capability to create and clearly explain team objectives and write procedures for others to follow
  • Demonstrated ability to problem solve with a deep understanding of engineering fundamentals
  • The knack for motivating a team and ability to estimate team effort and create predictable schedules
  • Broad measurement instrument knowledge and experience with data analysis
  • Knowledge of FDA’s Quality System Regulations (QSR’s) and/or ISO 13485 and ISO14971

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