Team Lead, Manufacturing Engineering (Process Improvement)

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

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Responsibilities:

• Lead a team of engineers focused on any one of the following Manufacturing Engineering areas (detailed below) as required - CAPA, Design, Manufacturing or NPI.
• 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.

• 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.