Manufacturing Engineer 2 - Process Improvement (12 Months)

The Manufacturing Engineer 2 (Process Improvement) will be responsible for key activities across a variety of manufacturing engineering disciplines, predominantly the area of Process Improvement. Key activities will include leading projects to either introduce or support and improve existing products. More specific details are listed below.

Reporting to: Manager, Manufacturing Engineering  

Find out more about Cook Medical here

• Identify and undertake projects focused on the successful implementation of:
• o Process changes that will improve existing device quality, performance, and efficacy.
• o 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).
• Other General Responsibilities
• Ensure that all activities are in compliance with:
• o Cook’s Code of Conduct.
• o Cook’s Quality System requirements.
• o 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.
• Knowledge of relevant ISO, EU, FDA medical devices standards regulations is required.
• High self-motivation, self-starter with a passion for excellence.
• Good working knowledge of Microsoft Office.
• Willingness and availability to travel on company business.