Job Purpose (Role Definition):
Responsible for the verification and validation of Inspiration Healthcare Group products.
Main Duties and Responsibilities:
* Conduct design and product verification and validation requirements according to Medical Device Regulations.
* Produce V&V plans, protocols, reports and perform the product testing where necessary.
* Design, develop and validate appropriate test methods, including automated tests.
* Perform data analysis/reviews of test results.
* Participate in risk management and FMEA exercises.
* Participate in requirement reviews.
* Interface with design, marketing, clinical, manufacturing and quality teams to ensure the product evaluation function is fully integrated within the project team.
* Conduct programmes for extended life/reliability testing of new products.
* Ensure usability is considered within the design of new products and that the usability process is applied.
* Interface with external test houses.
* Maintain and create biocompatibility reports and clinical evaluation reports.
* Undertake literature searches and perform analysis of novel technological/clinical research.
* Undertake all work in accordance with the quality management system.
Management Responsibilities:
None.
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