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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