Overview The primary function of this position is to manage a team of Engineers & Technicians focused on process improvements of devices post release to market and/or the introduction of new products (NPI), for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields.
Reporting to: Manager, Manufacturing Engineering Responsibilities Responsibilities: Lead a team of engineers in process improvement manufacturing engineering supporting across CAPA, Design, Manufacturing and NPI activities.
Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
Team Management: Mentoring, coaching and development of direct reports to attain best performance.
Perform routine appraisals to deliver best results and to obtain the maximum team Manage the activities of the Manufacturing Engineering/NPI team and hold regular team meetings.
Ensure KPI's and business metrics are achieved.
Work with Manufacturing Engineering Manager and other Snr.
Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Manufacturing Engineering team.
Collaborate with other Manufacturing Engineering Team members to ensure the effective completion of all activities associated with a Manufacturing Engineering project / objective.
Ensure effective reporting to the Manufacturing Engineering Manager.
Work closely to build effective relationships with other functions in particular Production, Quality, Regulatory and R&D teams.
Manufacturing/Process/CAPA/New Product Introduction (NPI) Responsibilities: Identify and guide the team in 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.
Provide support and technical guidance for the Supplier Change Notification (SCN) process.
Support Regulatory Affairs as required with engineering input for process related submissions and renewals post initial release of devices to market.
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.
Provide support and guidance to engineers and technicians focused on the support / timely completion of CAPAs (related to design, procedures and systems, or manufacturing processes).
The completion of the Investigation / Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved.
The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted.
The verification of effectiveness of CAPA's.
Liaise with R&D and Process Development teams to ensure the effective and efficient transfer of new devices from Development to Manufacturing.
Provide guidance and leadership on NPI projects to ensure successful and timely completion of same.
Other General Responsibilities Ensure the Manufacturing Engineering team are in compliance with: Cook's Code of Conduct.
Cook's Quality System requirements.
Company HR policies.
Liaise with other Cook manufacturing facilities.
Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
Responsible for operating general internal quality systems and documentation.
Act as a Designee for the Manager or Snr.
Engineer for document review as per Quality System Procedures.
Qualifications Formal production/engineering qualification and/or relevant experience in at least one of the following areas: Manufacturing Engineering/Device Design & Development/CAPA.
Strong proven people management skills.
Previous experience in a supervisory position desired.
The ability to supervise, lead and motivate a group of talented engineering staff.
Strong interpersonal skills and the ability to communicate at all levels of the organisation.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven problem-solving skills.
Good computer skills including knowledge of Microsoft Office.
Excellent organisational and team building skills.
High self-motivation.
Willingness and availability to travel on company business.
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