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.

R & D Engineer

Quality Technician LRT

Manufacturing Engineer

Quality Technician LRT

Background: 

The successful candidate will be based in the LRT /II Area but will be required to make regular visits to the CER.

Their main role will be to provide QT level support to the LRT and Incoming Inspection functions and to take ownership for driving all SCAR’s/ NCR’s raised within this area. This will include direct communication with suppliers. A secondary role will be to provide QA oversight in the CER.

Major Role & Responsibilities:

This role will involve reasonability for the following;

• Provide immediate, QT Level support to the LRT and Incoming inspection teams.
• Take ownership of all NCR’s raised within LRT/II area, conduct investigation and produce the necessary reports and documentation.
• This will require working closely and receiving input and support from relevant engineers/techs/team leads etc.
• Make daily visits to the CER’S for quality monitoring/Audit and SUB-LHR Review purposes.
• Be on call to provide QA input to line support teams in terms of product quality judgments.
• Preparation of Quality reports for Quality meetings and management reviews.
• Maintenance of quality metrics and reporting systems.
• 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 and drive 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.
• Good interaction and communication skills across functions.

Qualifications and Education Requirements:

• A minimum of 1 year experience in Quality Technician role in a medical device company is preferable Science/ Engineering/Quality Degree and relevant experience is preferable.

Skills Required:

• Good knowledge of PTCA catheter manufacturing processes and controls.

• Excellent Communication (both verbal and written) & interpersonal skills.
• Self-directed, can work independently, and proactive as a team member, being highly-motivated and result orientated.
• Ability to work in a fast-paced and deadline driven environment and stay focused.
• Detail-oriented and dependable.
• Good understanding of problem solving methodologies is required.
• Working knowledge of Microsoft Office packages – Word, Access, Excel and Outlook, database management software, and PCs.

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.

Manufacturing Engineer

Background:

The successful candidate will maximize the performance (quality, output volume, & cost) of manufacturing processes within GMIL, by providing high impact technical/operational support, and by developing processes to the highest possible standards.

They will co-ordinate and complete Kaizen activities and development of technicians with a mindset of improvement.

Major Duties & Responsibilities:

The role will involve the responsibility for the following:

• To implement appropriate process controls on to GMIL manufacturing processes for robust and repeatable commercial product manufacturing.
• Responsible for driving yield, availability and throughput improvement in CER.
• To maximise manufacturing process performance through effective implementation of Lean Sigma methodology.
• To apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness.
• 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 technical support to new product/technology introductions.
• To support the development of in-house Subject Matter Experts (SME) across the range of core technologies.
• To ensure that non-conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.
• To lead NCR, CAPA resolution in their area and to implement robust corrections to failures.
• To execute Validation activities as required in conjunction with the validation dept.
• To provide direction and guidance to technician team for assigned CER.

Qualifications and Education Requirements:

• Level 8 Degree in an Engineering discipline or equivalent.
• A minimum of 5 years of professional experience in a responsible Manufacturing Engineering/ Process Development role within Medical Device/Healthcare or similar type industry.
• Proven Implementation of Lean Manufacturing experience is essential.
• Six Sigma Green or Black Belt qualification is highly desirable and will have a significant advantage.
• Catheter manufacturing experience is highly desirable and would be an advantage.

 Skills required:

• Excellent Communication (both verbal and written) & interpersonal skills.
• Catheter assembly experience a definite advantage.
• Excellent Communication (both verbal and written) & interpersonal skills.
• Experience with team work and proven ability working with other functional roles.
• Excellent understanding of problem solving methodologies is required.
• Flexible, highly motivated individual, positive ‘can – do’ attitude and a proven track record in team leadership.
• Demonstrate a practical understanding of lean manufacturing principles and statistics.
• Some level of people management experience is desirable.