Mechanical Engineer

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 Major performance objectives & current reality or challenges to overcome. Internal interfaces (who will the position work with the most?) List the primary duties and responsibilities in order of importance. Begin each statement with an action & present tense verb Use gender neutral language such as s/he 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 Key: Laboratory work in a regulated environment.

Desired: Experience of working with gasses. Useful: Medical device testing. Qualifications Degree level BEng min. 2 years experience in a similar role