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

 

Production Line Leader: (Evening Shift)

Description:

To provide front line leadership and technical assistance to the production team in Goodman Medical Ireland.

Roles & Responsibilities: 

  • To provide first level leadership of Versatile Operators in the manufacture and assembly of medical devices. 
  • To schedule work for individual work stations and processes in line with GMIL manufacture schedule. 
  • To take a hands on role where necessary to ensure the timely completion of customer orders through the manufacturing process. 
  • To monitor and maintain production KPI’s showing actual line performance against standard, for workstation throughput; yield, and schedule adherence. 
  • To account for variances through accurate reporting of downtime and defect analysis. 
  • To co-ordinate effective training of Versatile Operators through close collaboration with Trainer and Production Team Leader , and to maximise the operational skill-base. 
  • To continuously monitor the performance of Versatile Operators to ensure compliance to all relevant policies and procedures (ref QA/Regulatory; Manufacturing; HR and EH&S)
  • To ensure effective implementation of corrective actions as part of the NCR/CAPA system
  • To organise additional working arrangements where necessary in conjunction with the Production Team Leader 
  • To communicate effectively with all Production Team and across all functions, to maintain a positive, progressive team-based manufacturing environment. 
  • To monitor the flow of materials and product from work station to work station, while ensuring that all documentation ( day sheet; Lot History Record, TA etc ) has been completed, and fully reconciled. 
  • To actively partake in the problem solving process and demonstrate an appropriate level of technical proficiency 
  • To take a leadership and where necessary, a participative role, in project teams to drive improvements 
  • To assist with line support, lot prepping, material and product testing, product building and all the cross departmental functions to ensure that the business needs are met in a timely manner. 
  • Deputise for Production Team Leader when required

Requirements

  • Degree/Diploma in Supervisory management/Production Engineering, or equivalent essential 
  • Minimum of 2-3 years relevant manufacturing experience in medical device sector 
  • Excellent communications skills and proven ability to liaise well with other departments 
  • The successful candidate will have a positive, can-do attitude with a willingness to learn.

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Production Team Leader: (Evening Shift)

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.

Roles & Responsibilities: 

  • Provide effective leadership of Line Leads; Trainers and Versatile Operators in the manufacture and assembly of Medical Devices in GMIL. 
  • Schedule work for individual work stations and processes in line with the GMIL manufacturing schedule. 
  • 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. 
  • Have a strong technical knowledge of medical device manufacturing technologies and processes.
  • Monitor and maintain production KPI’s showing actual line performance against standard, for work station throughput; yield, and schedule adherance. 
  • Account for variances through accurate reporting of downtime and defect analysis. 
  • Organise production teams effectively in providing appropriate capacity to meet business demands from a commercial and non commercial standpoint (new process transfers; process development/validations).
  • Monitor and co-ordinate training and development to have in place a competent and versatile workforce.
  • Ensure effective completion of corrective actions as part of the NCR/CAPA system. 
  • Drive continuous improvement projects which will have a positive impact (cost reduction) on GMIL operations.
  • Take a proactive role in the implementation of Lean Manufacturing systems and the application of Six Sigma problem solving methodology.
  • Maintain systems accuracy through compliance with GMP procedures and practices.
  • Maintain compliance with GMIL Environment, Health & Safety management system. 

 

Requirements

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

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Manufacturing Engineer

Description:

To maximize the performance (quality, output, volume, & cost) of balloon forming within GMIL, by providing high impact technical support in balloon processing area with special emphasis on tubing control and design. Co-ordinating and leading projects to improve repeatability and robustness of balloon forming processes against challenging timelines.  

Role & Responsibilities: 

  • To implement appropriate controls and approaches  to ensure first pass success during initial tubing qualifications and subsequent commercial builds. 
  • To apply a scientific approach to problem solving, combining analytical and experimental skills to optimise balloon forming performance. 
  • 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 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 help support the development of in-house Subject Matter Experts (SME) across the range of core technologies

Requirements:

  • A minimum of 5 years of professional experience in a responsible Manufacturing Engineering/ Process Development role, with a minimum of 3 years experience in balloon forming in a Medical Device/Healthcare Environment.
  • Experience designing and creating specifications for balloon tubing
  • Extrusion experience is a distinct advantage
  • Degree in Polymer Science/Material Science/Manufacturing Engineering

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Lead Automation Specialist

Description:

In the role of Lead Automation Specialist you will be expected to provide effective leadership to a team of Automation Engineers & Technicians, and manage the project team from design concept to implementation of the automation solution. You will be expected to manage the delivery of all site automation requirements required to support the GMI business through the use of internal and external resources; to develop relationships with external vendors to identify suitable resources that can be utilized to support issues resolution when required; to develop, execute and communicate a GMI site automation strategy looking at long-term issues with support and reliability etc, and to  develop medium to long-term capital investment plans for site automation systems.      

Role & Responsibilities:    

  • To provide specialist technical knowledge and project management expertise to the Automations engineering team at GMI.
  • To lead the GMI Automation team to deliver site automation projects, developing project scope, budget, capital approval and implementation plan.
  • To be responsible for maintaining control of the automation cost within annual budget.  
  • To manage and develop the staff in the automation engineering department through involvement, delegation, and regular reviews of performance.
  • To work closely with Manufacturing engineering/Product R&D within GMI, GMIC and Nipro to design/develop future products/processes leading to more cost effective manufacturing capability at GMI.  
  • To have overall responsibility for implementing capital expenditure projects and budget preparation for the GMI plant. 
  • To maintain control of financial and human resources of the automation engineering department in compliance with GMI policies and systems. 
  • To develop, establish, and maintain the infrastructure and systems of control required to achieve conformity to product and servicing requirements including control of the design and build phases ( CE-Mark, ISO13485 )  
  • To liaise on a cross-company basis with operations, engineering, R&D, marketing, manufacturing staff.
  • To make provisions for having Production Engineering Support available to existing Production Processes
  • To scope out automations projects with due regard to objectives; need, cost, risk, lead time and resources.
  • To identify & implement improvement opportunities on existing processes to include; lower costs, higher efficiency, higher capacity, greater process capability, higher levels of operator comfort & work station satisfaction and greater compliance.
  • To manage the installation and qualification of new or additional processes.  
  • To manage the development and delivery of all automation KPI’s in association with plant KPI’s. To propose and implement measures for business risk minimization and disaster recovery.  
  • To maintain an oversight of New Product Introduction to GMI and how this can impact on custom equipment requirements.
  • To manage the development of concept designs, with estimate of costs, as part of the capital requisition process.
  • To understand the automation resources skill set and capabilities and to plan the development of the team.
  • To provide effective supervision of people which includes headcount planning; recruitment and selection; training & development; timekeeping and attendance; resolution of issues, and timely completion of annual performance appraisals        

Requirements:

  • Successful candidate must have a track record of success in an engineering environment, an Engineering Degree or equivalent and at least 10 years’ experience in medical device manufacturing environment is required, with at least 5 years at supervisory/managerial level  
  • A background in machine building, automation, polymer processing, moulding is desirable.  
  • Excellent interpersonal and communication skills.   
  • Strong planning and organizational ability.   
  • Track record in project management.   
  • Strong engineering background with good analytical skills.           

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Quality Technician (Evening Shift)

Description: 

This person 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. You will also be required to conduct process audits.

Role & Responsibilities: 

  • Provide hands on line support to the mid-shift catheter and balloon production lines acting as a key member of the line support team.
  • Ensure effective and efficient line handover from Day Shift to Mid Shifts.
  • 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.
  • 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.
  • Work with the Senior QE to actively implement the same LMS systems and methodologies as on the day shift.
  • Acts as an effective team member in supporting quality disciplines, decisions and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communication and resolving quality issues.
  • Ensure regulatory compliance to GMP for all medical device regulatory agencies.
  • Reporting Functional area Quality Metrics.
  • Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.
  • Conduct internal quality audits to ISO and GMP requirements.

Requirements:

  • 2 years industry experience in a medical device manufacturing environment and within a QA role is preferable. 
  • Science/Engineering/Quality Degree and or relevant experience required.
  • Experience within a hands-on line support type role is highly desirable.
  • Good understanding of problem solving methodologies is required.
  • Excellent Computer Skills (Word, Excel, PowerPoint and Access).
  • Excellent communication (both verbal and written) & interpersonal skills.
  • Flexible, highly motivated individual.

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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