Verification and Validation Test Engineer

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Position Summary

The Verification and Validation Test Engineer is responsible for planning and executing product tests as part of new product development and sustaining engineering projects.  The Verification and Validation Test Engineer ensures that products are verified and validated in compliance with InGeneron procedures, external standards/regulations and industry best practices.Reporting to the Director of Product Engineering and located in our Houston, TX office, the position may have approximately 10% travel, generally to the US, though to include the EU.

 

 

Responsibilities

  • Lead design verification and validation activities as part of a cross-functional project team
  • Contribute to creation of product requirements and specifications, helping to ensure design inputs are testable and clearly defined
  • Develop test methods based on product requirements
  • Work with design engineers to conduct development and characterization testing of new concept designs
  • Plan and carry out test method validations, including measurement system analysis with tools such as gage R&R
  • Develop the verification and validation strategy for new devices, including preparation of verification and validation plans and protocols
  • Carry out or oversee testing activities, working with InGeneron lab personnel and engineers
  • Manage testing being carried out by external test houses
  • Ensure testing is planned and carried out in accordance with company QMS procedures
  • Carry out statistical analysis, including sample size determination and analysis of test results
  • Write clear and concise test reports and other documentation
  • Contribute to design and product reviews
  • Employ good documentation practices
  • Provide support during in internal and external audits
  • Plan and carry out qualification of test equipment

 

 

Employment Type

  • At InGeneron Inc, Houston, TX
  • Full-time
  • Benefits offered
  • 401K, Dental, Life, Medical, Vision

Requirements

  • Bachelor’s Degree in science or engineering
  • 3+ years’ verification testing experience, preferably within the medical device industry
  • Proficient knowledge of medical device QMS and Design Control requirements, including ISO 13485 and 21 CFR part 820
  • Understanding of standards related to medical device development, including IEC 60601, IEC 62366, ISO 10993, ISO 11607 and ISO 14971
  • Proficient computer skills, including Microsoft Office applications
  • Excellent communication skills
  • Excellent organizational skills

 

Please e-mail your resume to careers@ingeneron.com or contact us at any time if you have questions.