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
________________________________________________________________________________________________________________________________________________________________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
