Mechanical Engineer | Runcorn | Hybrid | Ref: 7714
The focus of this role is mechanical engineering to support medical device development of clients Portable Oxygen Concentrator product line. Duties will include NPI design work, contributing to the management of projects to agreed schedule and cost, performing engineering changes, working with suppliers to help ensure ongoing product quality, and undertaking verification and validation activities. The post-holder also be expected to build expertise and an excellent understanding of the Portable Oxygen Concentrator operating principle.
Performance Objectives and Responsibilities
* Mechanical aspects of NPI Projects and engineering changes as assigned are completed on time and to budget.
* Ensure that product validation activities are completed accurately to agreed timescales.
* Improve the efficiency of validation testing and test laboratory throughput.
* Undertake design and validation tasks as assigned.
* Good understanding of regulations relevant to medical device development, including ISO 13485, ISO 60601 and ISO 14971. Training will be provided as needed.
Skills and Competencies
* Laboratory work in a regulated environment.
* Experience of working with gasses.
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