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TMV Engineer

Summary:

This consultant role will assess, and where necessary, remediate test methods at Endotronix, a medical device start-up in Lisle, IL.

Endotronix is a privately held, development stage, venture capital funded, medical device company engaged in the field of wireless health monitoring. Endotronix has developed a next generation technology for measuring blood pressure in key areas of the human circulatory system using tiny implanted sensors and a small, handheld reader device.

Deliverables:

  • Act as the leader in the Endotronix effort to assess and remediate test methods and test equipment
  • Create an inventory list of all test and inspection methods executed at Endotronix (this includes design & development activities, manufacturing, incoming inspection, etc.) and a list of all test equipment
  • Assess validation and calibration status of test equipment and remediate as necessary
  • Assess the adequacy of test method validations that have been performed and documented
  • Assess test method transfer activities
  • Identify methods that have no test method validation conducted
  • Develop a gap assessment of current methods against quality and regulatory requirements
  • Remediate and validate design test methods; write protocols; execute validations; write reports
  • Write and implement a test method validation SOP.
  • Acting as a SME, train Endotronix employees on the principles of test method validation and the SOP
  • Coach other team members as SME on MSA process
  • If required, develop, validate and implement test methods

Sthree US is acting as an Employment Business in relation to this vacancy.