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.
- 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.