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 position.

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Control Systems Validation (Associate Engineer)

Description: 

Reporting to the Snr Validations Engineer the Computer Systems Validation (AE) will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions.

Role & Responsibilities:  

  • Coordinates and communicates all testing with affected functional groups and evaluates test results
  • Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards
  • Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
  • Develop and communicate requirements for quality performance, continuous improvement infrastructure for critical software installations.
  • Write validation plans, reports and procedures.
  • Execute manual tests for software and system validation. Carefully analyse and document test results.
  • Assist software system developers and subject matter experts in designing, documenting, performing and improving verification tests.
  • Ensure validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate.
  • Coordinate and participate in the development, testing and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software.
  • Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage.    

Qualifications and Education Requirements:

  • Requires a Level 8 or higher degree in an engineering or science discipline with a minimum of 2-3 years of related experience (medical device/pharmaceutical preferred).
  • Experience in medical device/pharmaceutical industry in the development and deployment of quality systems, process controls and continuous improvement systems.
  • Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA
  • Knowledge and working application of validation principles, guideline and industry practice, risk assessments, CAPA, change control.
  • MS Office competency demonstrated.
  • Excellent interpersonal, verbal and written communication skills.
  • Adaptable and able to work in a fast paced, dynamic work environment.  
  • Able to management multiple projects with competing schedules.
  • Knowledge of software development methodologies.
  • Knowledge of ERP, database systems and architecture.
  • Knowledge of PLC programming methodologies and systems.

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Process Development Engineer (R&D)

Description: 

Reporting to the R&D Manager, the Process Development Engineer will be involved in the project of transitioning a PTCA stent catheter from R&D to commercial phases. The engineer will work on both R&D and process development elements in this and other projects. The engineer will be technically competent as well as competent in problem solving, data analysis, report writing and project management skills.

Role & Responsibilities:  

  • Manage projects transitioning from R&D to commercial phases
  • Complete evaluation, testing, analysis and reporting to establish performance of various products/processes
  • Schedule and manage development builds and testing
  • Specify, source, test and approve material  
  • Prepare and lead reviews, including R&D design reviews
  • Create and maintain design-related technical information (lab notebooks, protocols, validations, manufacturing documents, etc.) to support design history file
  • Train operators/trainers in various new process steps
  • Understand and troubleshoot complex processing equipment
  • Support other R&D projects on an on-going basis
  • Work closely with manufacturing engineers during the handover period to commercial operations

Qualifications and Education Requirements:

  • Qualified to degree level in engineering, science or related discipline
  • Knowledge of PTCA/stent catheter manufacturing processes essential
  • Strong hands-on technical ability
  • Technical drawing experience essential
  • Knowledge in the use/processing of a variety of materials (plastics, metal, adhesives, etc.)
  • Understanding/working knowledge of relevant FDA/BSI standards and regulatory requirements
  • Experience in risk management/IS014971
  • Strong project management and leadership skills essential
  • Strong report writing skills essential
  • Good working knowledge of statistical and structured problem-solving techniques 

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Process Technician (Mid Shift)

Description: 

As Process Technician in a catheter manufacturing area you will provide support to production by troubleshooting process issues effectively, developing appropriate solutions and by implementing process improvements. Working as part of the engineering team, your key responsibility is to optimise process capability and support sustainable manufacturing performance.

 

Role & Responsibilities:  

  • Ensure procedures are adhered to and followed by self and others. 
  • Identify and lead Kaizen projects that will, improve capacity, yield, downtime & set up times etc. 
  • Complete Reject review and analysis & provide feedback & product knowledge transfer to operators and Core Team. 
  • Identify improvement opportunities that will improve capacity yield, downtime, set-up times etc. 
  • To carry out process development work on existing and new equipment/processes 
  • Carry out in-process testing, monitor performance and carry out interventions as necessary on equipment / process 
  • To carry out validation activities as directed by Manufacturing Engineer. 
  • To summarise, analyse and draw conclusions from test results leading to effective technical resolution of issues. 
  • To report and present data in a structured and competent manner, where required in the form of engineering reports/NCR’s, CAPA investigations etc. 
  • To participate and lead investigations as requested by GMIL using A3 problem solving tools. 
  • To carry out PM’s and monitor their effectiveness 
  • Update LHRs/MPIs, Drawings, PM’s as necessary 
  • Responsibility for ensuring all spare parts are controlled under the spare parts database 
  • To develop with Manufacturing engineers new methods, processes for balloon forming and to monitor changes in balloon forming technologies. 
  • Troubleshoot and repair equipment issues as they arise, document solutions for referral and where possible introduce robust corrective actions.

Qualifications and Education Requirements: 

  • Requires a Diploma/Degree in Engineering or equivalent 
  • Industry experience is preferred, however training will be provided on the job 
  • Excellent computer skills 
  • Demonstrated ability in troubleshooting is an advantage 
  • Experience of process improvement development a distinct advantage 
  • Have good Quality Awareness. 
  • Problem solving skills and knowledge of DMAIC and A3 tools 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

The Quality Technician 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. This person will also be required to work within a team structure to manage the production lines.

Role & Responsibilities:

  • Provide hands on line support to the catheter and balloon production lines acting as a key member of the Line support team
  • Work with the senior QE to actively implement Quality systems and standards.
  • Ensure effective and efficient line handover from Day-Mid shift.
  • 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
  • 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
  • Identify process & 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
  • Initiating and completing non conformance reports & investigations.
  • Good interaction and communication skills across functions.

Qualifications and Education Requirements:

  • Min 2 year industry experience in a medical device manufacturing environment and within a QA Role.
  • Relevant qualification in a Science/ Engineering/Quality Degree background and relevant industry experience
  • 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)
  • Experience of working in a team and with cross functional teams.
  • Flexible, highly motivated individual with a can-do attitude

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Trainer (Evening Shift)

The function of Trainer in GMIL is to work as part of the Core Team and to provide operational and technical training to Manufacturing Operators and any other members of the Core Team, enabling them to manufacture GMIL products to the specified quality and regulatory standards in an efficient and cost effective manner.

Role & Responsibilities:

  • To co-ordinate the training of production operators on manufacturing processes in conjunction with area line Leads and supervises to ensure maximum competency, versatility and achievement of work-step targets and yields.
  • To monitor progress of trainees throughout their training period, with regard to product knowledge, quality, efficiency, safety requirements.
  • To maintain files in relation to versatility, training plans, and individuals training files
  • To participate in induction programme for new employees by assisting in the design and delivery of induction modules.
  • To complete audit preparations and maintain areas to required regulatory standards
  • To participate in the daily Core Team meetings and weekly production team meeting
  • To complete scheduled line walks and all related activities
  • To provide effective line support in relation to line issues including quality, equipment, process and production including the completion of first pass maintenance, line clearance, adding new product, reject reviews, CTQs, NCRs, CANs, TAs.
  • To maintain GMP / Housekeeping, GDP, Line Clearance and Best Practice standards at a high level within the production area
  • To continuously review the effectiveness of training, on-going and completed, in relation to Quality, Health & Safety and Environmental criteria and to make recommendations for improvements in these areas.
  • To promote awareness of safe working procedures, regulations and safety rules and participate in Quality, Safety, Productivity and Environmental improvement
  • To carry out routine Training audits.
  • To keep training metrics updated and provide weekly reports.
  • To provide clear, concise, prompt updates to all team members and ensure line issues are communicated promptly and across shifts
  • To support Site/Global initiatives from a training perspective.
  • To work with Engineering and other Departments on new product introductions
  • To provide cover for absent trainers when required

Qualifications and Education Requirements:

  • Experience in the Medical Device manufacturing / Cleanroom environment is essential
  • Proficient in several work steps within the Cleanroom
  • Good working knowledge of Microsoft Office packages including Word, PowerPoint and Excel
  • Excellent communications and interpersonal skills
  • Knowledge of POBA Catheters and stents is essential
  • Familiarity with EH&S standards and practices.
  • Good organisational skills and the ability to maintain accurate records.
  • Ability to work independently or as part of a team.
  • Strong commitment to Quality, Safety and GMP standards

We ask that all prospective candidates read our Data Protection Policy document before completing the Application form below.

The document can be viewed on this page, or downloaded as a PDF here

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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By ticking on ‘I agree’ you are actively consenting to transfer your personal data to Goodman Medical Ireland Ltd and confirm that you have read the ‘Data Protection Policy for Applicants’.


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