Senior Manufacturing Engineer, NPI

2 weeks ago

Limerick, Ireland Cook Medical Full time

Overview

The primary purpose of this position is to lead manufacturing engineering projects and to provide technical support and guidance across manufacturing engineering activities as carried out in Cook Medical.

Reporting to: Manager, Manufacturing Engineering

Responsibilities

Lead/Support a team of Manufacturing Engineers to ensure that agreed project timelines and targets are met. Identify and drive improvements to the processes used in CIRL to deliver NPI and PD projects. Develop a detailed knowledge of the regulatory requirements pertaining to NPI and PD projects in CIRL. Drive the Cook Medical compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met. Liaise with other Cook manufacturing facilities. Support other cross functional groups to achieve company goals. Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies. Process Design – working with cross functional elements to drive design changes for products, business and compliance requirements. Lead production equipment issue resolution through Green Belt or Problem-Solving events as required. Process Improvement: Cost reductions projects. Promote the Continuous Improvement program, behaviours, and culture at Cook. Line support: production support and maintenance activities. Product transfers from Cook sister companies. Product transfer from Design to Manufacturing production. Equipment transfers from Cook sister companies \ new technology sourcing and introduction. Delegate for Manager, Manufacturing Engineering, to include review and approval of change requests and other quality system documentation requiring senior engineering sign-off. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

Bachelor’s degree required, preferably in engineering or a related field. Minimum of 5 years’ relevant experience is required. Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation. Willingness to seek out and drive improvement. Proven project planning skills and the ability to execute projects in a timely and effective manner. Team Player with ability to develop strong working relationships. Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence. Must be able to work in a fast-paced environment. Excellent attention to detail. Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820 is preferred. High self-motivation, self-starter with a passion for excellence. Good working knowledge of Microsoft Office. Willingness and availability to travel on company business.

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