Manufacturing Engineer 2
Cook Medical
- Limerick
- Contract
- Full-time
- Identify and undertake projects focused on the successful implementation of:
- Process changes that will improve existing device quality, performance, and efficacy.
- Cost reduction and yield/efficiency improvement opportunities.
- Provide engineering input and support for the investigation and resolution of Non-Conformances associated with devices post release to market.
- Support Regulatory Affairs as required with engineering input for process related submissions and resubmissions post initial release of devices to market.
- Provide engineering input and support to those responsible for Vendor instigated changes (Supplier Change Notifications).
- Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
- Responsible for process engineering layout plans and implementation in relation to line extensions or redesign.
- Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
- Participate in engineering projects in any one of the following areas - CAPA, Design, Manufacturing, EHS or NPI.
- Collaborate with other Engineering teams to ensure the effective completion of all activities associated with an Engineering project / objective.
- Ensure effective reporting to the Manager Manufacturing Engineering.
- Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory Affairs teams.
- Lead or participate in engineering tasks focused on the support / completion of CAPAs, process validations and pFMEA activities.
- Support and/or lead the introduction of new products into CIRL directly from design or transfer from a sister entity.
- Support and/or lead Continuous Improvement activities to deliver benefit to key business metrics.
- Development of project deliverables such as BOM’s and Production Documentation (Including IQC and Work instruction creation).
- Source and install new equipment requirements into manufacturing in accordance with Cook Medical’s quality system.
- Work closely with the Machine Shop to develop jigs, fixtures, and tooling to improve Manufacturing efficiencies.
- Support with defining maintenance and calibration requirements for manufacturing equipment both new and improve existing in accordance with Cook Medical’s quality system.
- Prepare, review and approve change orders and other quality system documentation
- requiring manufacturing engineering sign-off.
- Develop Work Contents for Manufacturing Flow lines by completing Time studies, removing nonvalue add waste and Generating standard of work.
- Development of project deliverables such as BOM’s and Production Documentation (Including IQC and Work instruction creation).
- Plan and execute improvement projects to ensure that project timelines, quality and cost targets are met.
- Deputise for Manufacturing Engineering Manager/Manufacturing Engineering Team Lead
- Ensure that all activities are in compliance with:
- Cook’s Code of Conduct.
- Cook’s Quality System requirements.
- Company HR policies.
- Liaise with other Cook manufacturing facilities as required.
- Bachelor’s degree is desired, preferably in engineering or a related field and / or relevant experience.
- Minimum of 3 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.
- Hybrid Work Model
- Company sponsored Defined Contribution pension scheme
- Medical Health Insurance cover for you and your immediate family
- Life Assurance and Income Protection cover
- Educational Assistance
- Performance related Bonus
- Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
- Fully equipped gym on site
- 39-hour week with flexible start & finish times
- Paid time off to participate in volunteer activities
- Free parking
- Subsidised restaurant
- Sports & Social club