Senior Sustaning Engineer Technical

Senior Sustaning Engineer Technical

Cook Medical

Limerick, Ireland

Overview

The primary function of this position is to manage key engineering projects within the Post Market & Manufacturing Engineering function and to give technical leadership to an assigned cross functional team. Projects will be focussed on devices post release to market for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields.

Responsibilities

  • Lead and give technical direction to key engineering projects focused on any one of the following Post Market & Manufacturing Engineering areas (detailed below) as required - CAPA, Design, Manufacturing or NPI (New Product Introduction);
  • Provide leadership and mentoring to team members to ensure the effective completion of activities associated with their role within the project team;
  • Work with Post Market Engineering Manager/ Manufacturing Engineering Manager and other Senior Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Post Market & Manufacturing Engineering group;
  • Develop and implement key processes for the effective running and tracking of projects within the Post Market & Manufacturing Engineering teams;
  • Ensure effective reporting to the Post Market Engineering/ Manufacturing Engineering Management team;
  • Manage and drive project activities to ensure timely completion of project milestones;
  • Represent project teams at key review meetings, e.g. CRB, PMS etc.;
  • Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.

CAPA

  • Lead and direct project team(s) focused on the support/completion of CAPAs (related to design, procedures and systems, or manufacturing processes);
  • Lead and support the completion of Investigation/Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved;
  • Identify/develop innovative solutions to issues. Develop test methods and fixturing to verify/validation solution, analyse test data and interpret to identify optimal solution;
  • 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;
  • Ensuring that CAPA’s are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders;
  • Where Engineering are not the CAPA assignee/process owner work closely with CAPA/Process owners to provide guidance on items above ensuring a consistent approach and outcome across all functions on site.

Design

Lead and direct teams in the successful implementation of:

  • Design changes that will improve existing device quality, performance and efficacy;
  • Cost reduction and yield/efficiency improvement opportunities;
  • Supplier instigated changes and line extensions;
  • Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market;
  • Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents;
  • Maintenance of the Risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis);
  • Support the post market surveillance of devices in terms of complaint investigation and risk analysis;
  • Provide engineering support for post market clinical studies if required;
  • Work with CAPA team as required to Root Cause CAPA’s and implement changes associated with same.

Process

Lead and direct project teams in the successful implementation of manufacturing/process changes that will:

  • Improve existing device quality, performance and efficacy;
  • Generate cost reduction and yield/efficiency improvements;
  • Lead and support the completion of Investigation/Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved;
  • Provide engineering input and support for the investigation and resolution of Non Conformances associated with manufacturing of devices post release to market;
  • Support Regulatory Affairs as required with engineering input for process related submissions and renewals post initial release of devices to market;
  • Provide engineering input and support to those responsible for Supplier instigated changes;
  • Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Post Market cycles;
  • Generate/support the layout plans and implementation of processes in relation to line extensions or redesigns;
  • Support the post market surveillance of devices in terms of complaint investigation and risk analysis.

Other General Responsibilities

Ensure the Post Market/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 Post Market Engineering Manager/Manufacturing Engineering Manager or Senior Sustaining Engineer – Team Lead 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/Quality Engineering/Manufacturing Equipment & Development/CAPA;
  • Strong proven project management/team leadership skills. The ability to 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;
  • Experience in the application of Lean Manufacturing techniques;
  • 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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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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