**Overview**
The Manufacturing Engineer 2 (Process Improvement) will be responsible for key activities across various manufacturing engineering disciplines, predominantly the area of Process Improvement.
Key activities include leading projects to either introduce or support and improve existing products. More specific details are listed below.
**Reporting Structure**
This role reports directly to the Manager, Manufacturing Engineering.
**Responsibilities**
The Manufacturing Engineer 2 (Process Improvement) is accountable for the following:
Project Management
* Identify and undertake projects focused on the successful implementation of process changes that improve existing device quality, performance, and efficacy.
* Lead cost reduction and yield/efficiency improvement opportunities.
Engineering Support
* 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).
Cross-Functional Collaboration
* Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
* Collaborate with other Engineering teams to ensure the effective completion of all activities associated with an Engineering project/objective.
Process Engineering
* 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.
Project Participation
* Participate in engineering projects in any one of the following areas: CAPA, Design, Manufacturing, EHS, or NPI.
Communication and Reporting
* Ensure effective reporting to the Manager, Manufacturing Engineering.
* Work closely with other functions, particularly Production, Quality, and Regulatory Affairs teams, to build effective relationships.
Continuous Improvement
* Support and/or lead Continuous Improvement activities to deliver benefits to key business metrics.
* Development of project deliverables such as BOMs and Production Documentation (including IQC and Work instruction creation).
Compliance and Governance
* Ensure that all activities are in compliance with Cook's Code of Conduct, Cook's Quality System requirements, and Company HR policies.
Qualifications and Requirements
The ideal candidate will possess a Bachelor's degree in engineering or a related field, and/or relevant experience. Minimum of 3 years' relevant experience is required. Strong interpersonal and organisational skills, ability to communicate at all levels of the organisation, and willingness to seek out and drive improvement are essential. Proven project planning skills, ability to execute projects in a timely and effective manner, and team player qualities are also necessary. Demonstrated problem-solving skills, high self-motivation, self-starter with a passion for excellence, and excellent attention to detail are highly valued. Knowledge of relevant ISO, EU, FDA medical devices standards regulations is required. Good working knowledge of Microsoft Office and willingness and availability to travel on company business are also desirable.