Team Lead, Manufacturing Engineering (Process Improvement)

Team Lead, Manufacturing Engineering (Process Improvement)

Cook Medical

Limerick, Ireland

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.

Responsibilities

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.

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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