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

 

Quality Engineer

Description:

This role will include co-ordinating all customer complaints, processing and controlling NCR documents, the implementation of process controls, CAPA systems, and day to day problem solving, you will also be involved in the development of quality metrics and reporting systems and will be required to conduct Internal Audits. 

Role & Responsibilities:

  • Identify and implement effective process control systems to support the development, qualification and on going manufacturing of products to meet or exceed internal and external requirements
  • Establish tools for monitoring and communication of quality system performance metrics on an on-going basis and rolling up to management review
  • Receive, co-ordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
  • Complete investigation and analysis of customer complaints
  • Drive continuous improvement initiatives and quality initiatives.
  • Ensure an efficient process is in place for the review of batch manufacturing records, process support documentation (e.g. NCR records) in support of product release for devices in line with supply chain
  • Direct Involvement in operations area projects and initiatives i.e. Six Sigma improvements, Lean etc.
  • Develop and implement quality metrics and reporting systems.
  • Preparation of Quality reports for Quality meetings and management reviews
  • Take a lead in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements
  • Acts 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
  • Perform an active role in quality planning and new product/process introduction.
  • Conduct internal quality audits to ISO and GMP requirements.
  • Responsible for the Supplier systems including the vendor audit and internal audit programs and execute audits as required

Requirements:

  • Min 4year industry experience in a medical device manufacturing, preferably with experience in complaints handling Science/ Engineering/Quality Degree and relevant experience
  • Previous experience within the medical device industry in Quality / Engineering is essential as is demonstrated use of Quality tools/methodologies including Six Sigma techniques
  • Experience in carrying our external and internal audits
  • Knowledge and Experience of Statistical Process Control would be beneficial
  • Excellent Computer Skills (word, excel, powerpoint and Access)
  • Excellent communication (both verbal and written) & interpersonal skills
  • Flexible, highly motivated individual and accountable

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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:

To analyse process capability and develop/ implement effective controls around processes.

  • 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 at least 2 years experience in an  Automation background or in Maintenance in and Industrial Environment or similar technical discipline.
  • Level 6 qualification in electrical engineering, mechanical, controls and automation, electronics or mechatronics engineering
  • Experience in electrical panel wiring is desirable
  • 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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Production Line Leader:

Description:

To provide front line leadership and technical assistance to the production team in Goodman Medical Ireland (GMI) to achieve sustainable manufacturing performance and operating standards.

Role & 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 the GMI manufacturing 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 work station 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 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
  • To 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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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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Buyer/Planner

Description:

Opportunity for a dynamic Planner/Buyer in a regulated manufacturing environment in Medical Device. Buyer/Planner responsible for all aspects of production planning , scheduling and purchasing. Support and maintain production plans and data integrity to support planning & operations. Support and maintain Master Production Schedule to support operations. Support and maintain TQ scheduling & machine loading to support operations. Support and maintain supply chain initiatives to support operations. Support and maintain life cycle management to support operations.Support and maintain Inventory Accuracy across the Warehouse and manufacturing Environment.   

Role & Responsibilities:  

  • Execution of Master Production Schedule and management of TQ schedule
  • Scheduling, management & monitoring of Value Stream production to meet market requirements
  • Provide interface between cleanrooms with regard to wok flow and scheduling lines and outputs
  • Update database daily with regard to MPS and weekly schedule
  • Keeping Production Plan updated on a weekly basis and check material availability.
  • Reconciling Material usage & Optimising the stock levels on site
  • Communicating with internal clients (Warehouse, Purchasing, QA) to ensure materials availability for production
  • Updating our Key Performance Indicators & internal documentation
  • Co-ordinate the purchasing and planning of all materials required by Production and Engineering using the GMI PO system.
  • Ensure that material ordering is within policy parameters thus maintaining agreed inventory levels.
  • Manage, monitor and report an optimal level of inventory to meet site KPI’s and production needs.
  • Lead inventory and warehouse related projects & Plan and schedule inbound materials supply.
  • Developing a weekly production plan for manufacturing areas.
  • Tracking progress against same through daily performance management meetings.
  • Escalating any issues as required to ensure the production plan is being met at all times.
  • Liaise with Engineering, Regulatory and QA to ensure product availability.
  • Proactively identify, report & resolve constraints within the end-to-end Supply Chain which will impact Customer Service and other key supply chain metrics.
  • Generate and present daily / weekly / monthly reports and metrics as appropriate.
  • Participate in continuous improvement activities across the full supply chain.

Requirements: 

  • Preferably have 2-3 years buyer/planning experience in an MRP environment.
  • Good presentation and communications skills (both verbal and written)
  • Strong Analytical skills – essential
  • Advanced MS Excel and Access
  • Must be a self starter and able to work on own initiative.

 

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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