Medical Device Development Engineer

ICDS Recruitment

Dublin North

Medical Device Development Engineer. Dublin. In support of its ongoing medical device development programme, our client requires a Development Engineer to support product and process development activities. The key outputs and deliverables of the role are as follows: Development of Class III medical devices and associated manufacturing processes, entailing: Device development based on outputs from product/process improvement feedback. Process development to facilitate manufacture of product, including implementing appropriate process controls. Development and validation of test and inspection methods. Requalification of devices and processes to support change implementation. Training of operators on developed processes Development of project documentation, with focus on detail and quality o Product specifications. Detailed product/tooling drawings. Generation and maintenance of manufacturing documentation (Manufacturing strategies, Process Flows, DMR, DHR. Development and updates of Risk Management documentation through entire product lifecycle. Planning and execution of verification and validation activities, including Procurement of capital equipment. Assisting in the generation of Validation Master Plans o Generating verification / validation protocols and reports. Execution of Equipment Validations (IQs/OQs) and subsequently Design Verification and Process Validation (OQ / PQs. Assist in managing vendor quality and providing technical support • Support Regulatory Affairs with submissions. All applicants must possess the following: Third level degree in Mechanical, Manufacturing or Production Eng or similar discipline with: • Minimum of 3 years experience in product / process development, ideally in Class II / III medical devices. • Design Skills involving 3D modelling. • Experience designing jigs and fixtures and developing automated processes. • Knowledge of materials and processing techniques (polymers, metals, ceramics), including rapid prototyping. • Knowledge of manufacturing processes within a clean-room environment. • Attention to detail and Quality Focus. • Strong communication skills. Although not essential, it is desirable if applicants have the following: • Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820. • Knowledge of anatomy and physiology. • Experience of lean manufacturing methodologies, DFM, DFA, DFI and 6-sigma • Experience with machine shop equipment. Person specification: You will be a motivated and enthusiastic individual and a self-starter capable of planning and managing their own responsibilities with little input. You will also be a team-player that can develop strong working relationships within a cross-functional team. Location: Based in Dublin. The role will involve some travel to UK. This job originally appeared on RecruitIreland.com.

2191 days ago