We are Hiring

Goodman Medical Ireland Limited (GMIL) is a progressive and dynamic manufacturer of medical devices, mainly concerned with the development and manufacture of cardiovascular devices and implants. GMIL has been operating successfully since 2004 and we have built our success on the belief that finding, employing and continually developing the right people is one of the keys to building a safe and effective medical devices.  

 We are currently recruiting for the following full time positions

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Process Technician:

Description:

 As Process Technician you will provide maximum support to manufacturing, by trouble-shooting processes effectively; by developing appropriate solutions, and by implementing process improvements. Working as part of the operations team, your key responsibility is to optimise process capability and support sustainable manufacturing performance

Role & Responsibilities:

  • To analyse process capability and develop/ implement effective controls around processes
  • To complete hourly line walks to support work station quality (yield and defect analysis) and throughput rates (hourly throughput against standard). 
  • Make interventions where necessary to improve performance
  • To carry out process development work on new/existing hardware
  • To complete daily checks on all equipment and record on machine check sheet provided.
  • To summarise, analyse and draw conclusions from test results leading to effective technical resolutions.
  • To present and report data in a structured and competent manner (i.e. analysis and presentation of yield/defect data daily, weekly and quarterly via report, to compile Engineering reports to support process validation activities.
  • To support processes by trouble shooting  product defects, process issues, identifying equipment functions and faults equipment adjustment and technical/process resource for set-up technicians and PBs, and project and production staff.
  • To support and execute product, process and equipment analysis and improvement projects as requested.
  • To Log and report downtime and any quality issues. 
  • To resolve yield issues and identify high loss rejects 
  • To attend weekly production meetings to report/highlight downtime & yield issues. 
  • To conduct cleaning duties on production equipment to help reduce & prevent rejects
  • Work as member of a core team to help resolve open issues drive process improvements in design, layout and operational performance.
  • To demonstrate good working knowledge and application of validation techniques and associated regulatory requirements
  • To actively promote and participates in a cross-functional teamwork environment
  • Trouble shoot and repair equipment and process problems 
  • Minimise costs through efficient use of equipment and processes 
  • To train Trainers & Production Leads on process changes/enhancements

Requirements:

  • Requires a Certificate /Diploma in Engineering
  • Minimum of 2 years experience in a medical manufacturing environment in Lean/Six Sigma
  • Good computer skills.
  • Experience of process improvement development a distinct advantage
  • Have good Quality Awareness
  • Problem solving skills a distinct advantage.
  • Good communication skills as well as ability to work in a team  culture are required.
  • Motivated to work on own initiative.

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Quality Technician (Day Shift)

Description: The ideal candidate will be working in the manufacturing area providing real time QA support to the Production line. This will include the implementation of process controls, CAPA systems, and day to-day problem solving.

Role & Responsibilities: 

  • Provide hands-on line support to the catheter line, acting as a key member of the Line support team
  • Work with the QE to actively implement the LMS systems
  • Direct Involvement in continuous improvement projects and initiatives
  • Maintenance of Quality metrics and reporting systems
  • Preparation of Quality reports for Quality meetings and management reviews
  • Provide support to the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements
  • Act as an effective team member in supporting quality disciplines, decisions and practices
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues
  • Ensure regulatory compliance to GMP for all medical device regulatory agencies
  • Suggest  changes in procedures and standards  to facilitate work efficiency and maintain quality
  • Reporting Functional area Quality Metrics
  • Conduct internal Quality audits to ISO and GMP requirements

 Requirements:

  • Minimum of 2 years industry experience in a Medical Device Manufacturing environment and within a QA role.
  • Educational Background in Science/Engineering/Quality is required
  • Experience within a hands-on line support type role is highly desirable
  • Good understanding of problem solving methodologies is required
  • Excellent Computer Skills including (MS Word, Excel, PowerPoint and Access)
  • Excellent communication (both verbal and written) & interpersonal skills
  • Flexible, highly motivated individual

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Production Team Leader:

Description:

The Production Team Leader’s role is to deliver the right production volume output, to the right quality standards, in an efficient and cost effective manner.

Role & Responsibilities:

  • To provide effective leadership of Line Leads; Trainers, and Versatile Operators in the manufacture and assembly of Medical Devices in GMIL
  • Ability to work in sync with all stakeholders including (Operators, Line Leaders, Senior Team Leader, Trainers, Technicians & Engineers) so as to maximise output, whilst also engaging and motivating the production team
  • To schedule work for individual work stations and processes in line with the GMI manufacturing schedule
  • To provide effective supervision of people which includes headcount planning; recruitment and selection & training and development, timekeeping and attendance, resolution of issues, and timely completion of annual performance appraisals.
  • To have a strong technical knowledge of medical device manufacturing technologies and processes
  • To monitor and maintain production KPI’s showing actual line performance against standard, for work station throughput; yield, and schedule adherence.
  •  To account for variances through accurate reporting of downtime and defect analysis
  • To organize production teams effectively in providing appropriate capacity to meet Business demands from  a commercial and non commercial standpoint ( new process transfers; process development/validations)
  • To monitor and co-ordinate training and development to have in place a competent and versatile workforce
  • To ensure effective completion of corrective actions as part of the NCR/CAPA system
  • To drive continuous improvement projects which will have a positive impact (cost reduction) on GMI operations
  • To take a proactive role in the implementation of Lean manufacturing systems and the application of six sigma problem solving methodology
  • To maintain systems accuracy through compliance with GMP procedures and practices
  • To maintain compliance with GMI Environment, Health & Safety management system

Requirements:

  • Supervisory management and relevant Engineering qualification essential
  • Minimum of 2-3 years relevant manufacturing experience
  • Excellent communications skills and proven ability to liaise well with other departments
  • The successful candidate will have a positive, can-do attitude, with a proven track record in team leadership.

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Automation Engineer

Description: To design and fabricate automation technologies (custom machines, upgrades/retrofits and robotics conveyor systems and automation lines) to factory approved standards within Goodman Medical Ireland. To work as part of the project team from design concept to implementation of custom built solutions.

Role & Responsibilities:

  • To evaluate process related problems and develop a precise design statement/brief
  • To develop concept designs with estimate of costs as part of the capital requisition process
  • To present design concepts for formal review
  • Develop scope of solution and review of costs
  • To complete 3D modelling of machine design specifying Actuators / Hardware / Control systems
  • Finalise capital spend and prepare capital requisition documentation
  • To present all aspects of design as part of formal machine design review process
  • Complete capital requisition
  • To procure quality components at appropriate cost and complete/oversee fabrication/wiring for machine build
  • To complete/oversee PLC programming / HMI programming and functional testing
  • To ensure all new machine builds are fully calibrated (i.e. temperature controllers / pressure gauges / force sensors etc.)
  • To perform detailed process review, establishing process development criteria & operating ranges for the machines
  • To complete detailed technical reports and approval documentation for release of new technologies to manufacturing.
  • To fully comply with all aspects of the GMIL Health & Safety Management System

 

Requirements:

  • Level 8 Engineering degree with 3+ years experience or Level 7 Degree with 5+ years experience in Automation Engineering
  • Extensive experience in designing fabricating and commissioning new machine technologies
  • Experience and proficiency in PLC programming is desirable and a distinct advantage
  • Experience with vision systems, robotics, data handling and SolidWorks 3D Modelling will be a distinct advantage
  • Strong communications skills, ability to demonstrate creativity and innovativeness
  • Good negotiation and presentation skills
  • Self motivated self starter, can be left to work on own projects
  • Strong interpersonal skills and team player abilities
  • Strong attention to detail and technical report writing skills.

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Document Controller

Description: The Document Controller will be reporting directly to the QA/RA Manager and will be the main point of contact for all Document Control within GMIL. The Document Controller will be working in a fast paced environment, working alongside multiple departments in communicating necessary changes, updates and processes etc.

Role & Responsibilities: 

  • Day to day running of the Goodman Medical Ireland Document Control System
  • Raising and processing, Change Approval Documentation
  • Circulation and control of approved records, review, rewriting and updating of documents
  • Filing and archiving of all documents
  • Environmental monitoring of the clean room
  • Review of LHR, LRT and other manufacturing / QA records
  • Updating and control of supplier records
  • Compliance to all Quality System and current GMP procedures and practices
  • Any other duties within the QA/RA department as defined by the QA/RA Manager
  • Conduct internal Quality Audits & support on site third party Quality Audits

Requirements:

  • Appropriate Quality qualification or relevant Document Control experience
  • Previous experience within the medical device industry in Quality / Engineering or related Discipline would be beneficial as would demonstrated use of Quality tools/methodologies
  • Proficient in Microsoft Office (Excel, Word, PowerPoint)
  • Good communication (both verbal and written) & interpersonal skills
  • Highly organised, methodical and systematic approach to work
  • High level of attention to detail required
  • Ability to work independently or as part of a team

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Automation Technician

Description: Reporting to GMIL Technologies Department, the Automation Technician must have strong electrical and mechanical skills. They will be responsible for completing electrical and mechanical assembly work on in-house custom made machines as well as upgrades and retrofits of existing equipment. They will also be responsible for maintaining and/or repairing manufacturing equipment at GMIL.  

Role & Responsibilities: 

  • Complete electrical wiring of electrical/control systems on equipment in accordance with design schematics.
  • Complete assembly of mechanical systems including pneumatics in accordance with design schematics.
  • Complete machine setup and functional checks.
  • Perform preventative and corrective maintenance, completing all associated paperwork and records to ensure high levels of up-time.
  • Follow systematic root cause problem solving and troubleshooting to resolve equipment issues.
  • Implement corrective measures to machine issues and propose preventative measures to prevent re-occurrence.
  • Assist with the commissioning of new equipment / projects.
  • Order and maintain appropriate stock of spare parts.
  • Complete assigned continuous improvement projects and train others as required.
  • Flexibility to travel to support new equipment .
  • Ability to explain an issue and communicate the path forward toward resolution.
  • Ability to work as part of a core team.
  • Actively promote and participate in a cross-functional teamwork environment.
  • Equipment adjustment and technical/process resource for production and/or process development staff.
  • Fully comply with all elements of GMI environment Health & Safety Management System.
  • Adhoc duties as required.

Requirements:

  • The successful candidate will preferably have an Automation background with at least 2 years experience with electrical and mechanical instrumentation.
  • Level 6 qualification in electrical engineering, mechanical, controls and automation, electronics or mechatronics engineering.
  • Experience in electrical panel wiring is essential.
  • Experience in interpreting technical drawings is essential.
  • Experience in mechanical / high volume automation / robotics desirable.
  • Qualified trades personnel with industrial experience will also be considered.
  • Experience in a medical device manufacturing environment desirable.
  • Experience in Pneumatics, Electronics, Programmable controllers, Vision Systems and Workshop machining desirable.
  • Strong mechanical problem solving skills essential.

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Manufacturing Engineer

Description:

To maximize the performance (quality; output volume, & cost) of manufacturing processes within GMIL, by providing high impact technical/operational support, and by developing processes to the highest possible standards. To co-ordinate and complete complex projects supporting the implementation of LEAN Manufacturing successfully against challenging timelines.  

Role & Responsibilities: 

  • To implement appropriate process controls on to GMIL manufacturing processes for robust and repeatable commercial product manufacturing.
  • To maximise manufacturing process performance through effective implementation of LEAN SIGMA methodology.
  • To apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness and efficiency.
  • To ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
  • To lead the conversion of manufacturing processes from batch manufacturing to single piece continuous flow manufacturing.
  • To support the development of new processes in conjunction with Process/Manufacturing/R&D Engineering ensuring that new processes are stable and capable.
  • To provide adequate technical support to new product introductions and change controls are effectively managed.
  • To ensure that non conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.
  • To successfully complete validations and process improvements using statistical tools and six sigma techniques.
  • To support the development of in-house Subject Matter Experts (SME) across the range of core technologies

 

Requirements:

  • Catheter manufacturing experience would be an advantage.
  • A minimum of 5 years of professional experience in a responsible Manufacturing Engineering/ Process Development role within the Medical Device/Healthcare.
  • Six Sigma Green or Black Belt will have a significant advantage.
  • Proven Implementation of Lean Manufacturing experience essential.
  • Degree in Mechanical Engineering /Manufacturing Engineering 

 

To submit CV: Simply complete the form below and attach your CV and cover letter, or email our Human Resources Department at hr@goodmanmedical.ie

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