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Job Description
An NPI Engineer is required by CareerWise Recruitment for our client based in Northern Roscommon, commutable from Mayo, Sligo, Leitrim and Longford. The NPI Engineer will manage projects and the identification, specification, introduction, management and validation of new equipment, processes, products and technologies, providing technical input and leadership on problem solving, resolution of technical processing issues and implementation of process improvements in the area.
Role of this position
1. Manage, develop and validate new processes including running trials/feasibility studies for new product/product iterations and new technology to demonstrate capability and achieve key project deliverables (Cpk, cycle times, lead-time, GM% etc..).
2. Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
3. Uses a science-based approach to develop processes, process improvements and technology improvements.
4. Understand current processes, taking a hands-on approach to understanding how these can be applied to new opportunities.
5. Work with equipment and material vendors to mutually understand their and our technical process challenges, to improve capability and eliminate cost.
6. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs.
7. Write and review new customer development proposals for development projects.
8. Identify, develop and implement plans for continuous improvement activities. Lead improvement initiatives as assigned including investigations, troubleshooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principles.
9. Project manage and lead cross-functional teams with responsibility for the introduction and validation of new processes/new technology.
10. Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with the quality system and the requirements of ISO13485, The Medical Device Regulation and FDA Quality System Regulations.
11. Assess customer's validation needs and propose innovative solutions.
12. Support teams to identify and specify new technology/tooling/materials required.
JOB REQUIREMENTS
1. Degree in a relevant engineering, science or an equivalent discipline.
2. 3+ years work experience in industry, Medical Device or manufacturing experience is essential.
3. Have the ability to effectively manage a simultaneous range of diverse activities.
4. A practical level-headed individual with strong technical ability.
5. Ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues.
6. Excellent project management skills, setting realistic objectives and delivering.
7. Energetic and driven self-starter, with good communication and influencing skills and the ability to effectively simultaneously manage a wide range of diverse activities.
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