MDR Product Development Engineer
This career defining opportunity is a key role within R&D and will focus on sustaining and iteration activity on our existing product portfolio. Initially the role will focus on review and remediation of our current product offerings to ensure compliance with MDR requirement and may progress to development and commercialisation of new and improved product offerings to better serve existing and new Customers. The successful candidate will have a high level knowledge of Design Control and a proven track record in Medical Device product development.
THE ROLE ……
- Work as member of MDR remediation Team to critically analyse & distil applicable regulatory standards & requirements, assimilate design data and generate/configure technical studies, justifications and rationales to fulfil requirements and augment design history files.
- Liaise and work effectively with Sales & Marketing, Regulatory, DA, QA, Operation, Planning and other critical functions to form a cohesive project Team ensuring all inputs and requirements are considered, included in project scope.
- Organise and execute design control activities such as User requirement review, risk analysis, product specification, Human Factors analysis, test method development and Design Verification & Validation in order to successfully bring product to Design Transfer stage.
- Generate and maintain required Engineering and Design documentation in line with the Quality Management System and associated regulatory requirements.
- Ensure that Design for Manufacturability and product cost impact (materials and processing) are considered in all decision-making right from early concept stage so as to ensure final design can be scaled seamlessly in to manufacturing at the required product cost.
- Performs other related duties and tasks as required.
- Degree in Engineering, Science or related technical field or with appropriate demonstrated experience.
- At least 5 years previous related experience in med device product development or equivalent.
- Experience in interpretation and application of MDR requirements in Med Device development.
- Demonstrated analytical problem-solving and innovative thinking.
- Good working knowledge of medical device materials and processes.
- Formal project management training an advantage.
- Strong interpersonal and organizational skills and the ability to work effectively as a team member.
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