1 jobs found in charfield

ResponsibilitiesRequirements capture to establish design inputs.Creation and execution of design verification and validation protocols.Critical review of design output through design review and user, design and process risk assessment.Development of processes to support design control activitiesKey requirementsA degree in Mechanical Engineering or similar relevant subjectA proven track record in medical product design, working on complex multi-disciplinary systems. Minimum 5 years’ experience.Experienced in the compilation of medical device (or combination product) DHFs which are clearly structured, flexible to technical change and auditable.Detailed practical application of ISO-13485, ISO-14971, EU-MDR and FDA 21 CFR.Good knowledge of current manufacturing techniques and technologyA natural ability to plan, identify critical paths and resolve problemsA natural aptitude towards structured problem-solving and decision-makingAbility to write clear and concise reportsProficiency in MS...