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.

Associate Validation Engineer

R & D Engineer

Manufacturing Engineer

Associate Validation Engineer

Background:

Reporting to the Snr Validations Engineer the Validation Engineer (Associate) 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.

Major Role & Responsibilities:

• This role will involve reasonability for the following;
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Participate in improvements and development 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.
• Write validation plans, reports and procedures.
• Assist Manufacturing Engineering and Automation Engineering in designing, documenting, performing and improving process validations. Ensure validation program meets requirements of ISO13485, PMDA where appropriate.
• 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, PMDA and GAMP 5 where appropriate.
• Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage.

Knowledge & Skills Required:

• Requires a Level 8 or higher degree in an engineering or science discipline.
• Minimum of 2-3 years of related experience (medical device/pharma preferred).
• Experience in medical device/pharma industry in the development and deployment of quality systems, process controls and continuous improvement systems.

R&D Engineer

Background: 

The successful candidate will design, develop, modify and evaluate medical devices.

They will use structured engineering, problem solving and statistical techniques to designs and develop new products and/or improve existing products whilst adhering to regulatory requirements, project deadlines and budget.

Major Role & Responsibilities:

This role will involve reasonability for the following;

• Design and set-up experiments, manage evaluation testing and work with suppliers/manufacturers in developing new and existing products.
• Actively involved in specifying, sourcing, testing and approving material.
• Prepare and lead critical technical design reviews, including preparation and presentation of supporting design documents.
• Project manage transfer of products from concept/design phase to commercial manufacturing.
• Follow design control procedure/standards in accordance with ISO13485.
• Create and maintain design-related technical notes (notebooks, protocols, validations, manufacturing documents, etc.) building a complete design history file.
• Compile and analyse operational, test and development data to establish performance standards for newly designed or modified products.
• Manage and prepare engineering test protocols and reports.
• Provide new design concepts.
• Work with relevant functions in transferring R&D projects to commercial operations.

Qualifications and Education Requirements:

• Level 8 Degree in an Engineering discipline or equivalent.

• A minimum of 4 years of professional experience in a R&D role within Medical Device/Healthcare or similar type industry.

• Strong mechanical design skills.
• Experience with design control and ISO1348.
• Catheter manufacturing experience is essential.
• Six Sigma Green or Black Belt qualification is highly desirable and will have a significant advantage.

Skills Required:

• Excellent working knowledge of Microsoft Office Packages including Word, Outlook, Excel, Project etc.

• Excellent Communication (both verbal and written) & interpersonal skills.

• Experience with team work and proven ability working with other functional roles.

• Knowledge of material properties.
• Strong project management and leadership skills essential.
• Experience in risk assessment and FMEA.
• CAD experience preferable.
• Knowledge in the use of a variety of materials (plastics, metal, adhesives, etc.).
• Knowledge of catheter manufacturing processes (bonding, moulding, etc.).
• Experience in bringing a product from concept/design phase to commercial manufacturing.
• Understanding/working knowledge of relevant standards and regulatory requirements.
• Good working knowledge in statistical process control and capability analysis using DMAIC and DOE techniques.
• Influential team member, fully motivated to achieve and demonstrate best practices.