• Implement any changes to the packaging line as a result of MDR.
• Ensure any MDR manufacturing changes achieve operational excellence.
• Ensure processes and procedures are in compliance with MDR regulations.
• Responsible for the installation, calibration and preventative maintenance of any process equipment related to MDR.
• Support any packaging test builds related to MDR changes to the product packaging.
• Support cross site engagement for any MDR components development activities.
• Undertake specific projects as designated in support of the MDR business unit objectives.

• Degree qualified in engineering, science, or a technical equivalent.
• 2-5 years of relevant work experience within the medical device industry.

• Exciting long-term daily rate contract role within a leading global healthcare solutions company
• Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry.
• Potential for a long-term opportunity within the organisation.

• Extensive Automation Experience
• Selenium & JAVA
• Regression Testing - Jenkins
• BDD Framework Experience
• Compiling Acceptance Testing
• Smoke Testing / Regression Experience

• Performance Testing Experience.

• Test Automation
• Selenium

• Competitive Daily Rate (€350-€400).

• Degree in Computer Science or similar field
• At least 2 years' experience in a QA Automation role
• Experience setting up test automation frameworks
• Knowledge of multiple automation tools like Codeception, Selenium etc
• Strong coding skills

• Competitive salary, based on experience
• Remote work flex (after Covid)
• Bonus
• Pension
• Sick Pay

Our client, a leading medical device company based here in Galway is looking for a Supplier Quality Engineer to join their team on a 12-month contract.

In this role you would be working with external suppliers as well as within a cross functional team to resolve supplier related issues. This person would be a driving continuous improvement while also driving key quality metrics across the Galway location.

Responsibilities.

• Communicate with management and project team about supplier performance.
• Support in review of supplier introduction and changes, coordinating activities with suppliers as well as cross functional teams to develop and implement appropriate strategies to qualify and support.
• Provide expert QE technical direction input to component qualification strategies.
• Ensure appropriate controls are in place at supplier based on risk associated with product or service.
• Develop and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP and quality standards are met.
• Define receiving inspection requirements as required and associated test method validation for all internal test methods.

Experience.

• Bachelor’s Degree in a relevant technical discipline such as Engineering or Science or another technical field.
• Minimum 5 years relevant experience.
• The ideal candidate is a team player with excellent communication skills both verbal and written.
• Knowledge of regulatory requirements and guidelines including 21 CFR parts 210,211, 21 CFR part 820, ICH requirements and ISO 13485 is an advantage.
• Previous experience in Supplier Quality would be an advantage.
• ISO 13485 Lead Auditor Certification would be an advantage.

If you would like to discuss this role, reach out to Rebecca O'Connor on 091 749265 or email 

roconnor@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Senior Industrial Engineer

As the Senior Engineer, you will be responsible for managing the Space Optimisation plan onsite in Galway. This will require strong project management skills, excellent communication and influencing skills.

What will you do?  

• Develop and maintain a 5-year Production Space Optimisation plan
• Responsible for ensuring that all approved moves align to the Production Space Optimisation plan
• Manage the portfolio of space moves for the campus
• Initiate or maintain work schedules and priorities for cross departmental space transfers
• Provide timely communication on project progress to all relevant cross-functional stakeholders, and across all levels of the organization, including the senior leadership team
• Work with the Industrial Engineering team on the implementation of the Production Space Optimisation plan
• Identify potential expansion options to meet future business needs for the campus
• Builds strong relationships and collaborates with Operations, R&D and PD
• Align closely with Facilities on all planned changes to the plant and off-site locations
• Support the development of the annual Global Facilities Master Plan (GFMP) for the Galway campus
• Liaise with finance to establish which projects are tracking to plan and how best to manage financial projections (F1, F2, F3, AOP)
• Influences, guides, and manages internal/external resources to achieve critical program goals
• Lead other site/department projects and programs as required
• Manage all Corporate requests regarding current space utilisation and development plans

What do you need?

• The position requires a bachelor’s degree and experience in high volume manufacturing.
• BS in Engineering or Science is required at level 8, 240 ETCS credits
• Must have proven business acumen, effective communication skills, demonstrated track record of project management execution, and leadership experience
• Engineering background and experience in medical devices industry preferred with exposure to Production Space Planning
• Demonstrate communication and influencing skills at the highest levels of management across a cross-functional organization.
• Must have experience managing and leading projects

For more information, please contact Emma on 091 455 307.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Senior Supplier Engineer | Galway | Permanent.

Our client, a global leader within the Medical Device industry is looking for a Senior Supplier Engineer to join their team on a permanent basis.  

You will be a part of the Materials Supplier Engineering Team where you will be concentrating on all aspects of supplier selections, processes, and material changes.

What you will be responsible for:

• You will be the technical lead on teams which have representatives from various departments.
• You will be responsible for Establishing & Achieving business objectives of the Team in terms of Quality, Cost and Service.
• You will provide guidance to other functional areas in applying Supplier Management system requirements
• You will drive continuous improvement of quality and quality systems, service capability and total cost of ownership throughout the supply chain.
• You will support investigations of material quality.
• You will also ensure that adequate Corrective Actions are identified, implemented, and controlled by Suppliers.
• You will work with Procurement, Supplier Quality Engineering, Receiving Inspection & Business units to ensure that components meet established requirements.
• You will contribute to the development, maintenance and improvement of Supplier Management Policies and Procedures.
• You will develop new Supply sources with Procurement Team.
• You will identify and drive Material Value Improvement Projects (VIP’s) throughout the Supply.
• You will communicate effectively with all Internal & External Stakeholders.

What we need from you:

• Bachelor of Science (NFQ level 8/ 240 credits) in Engineering, Life Science or Physics.
• People management experience is mandatory. 
• Minimum 5 years’ experience working in Supplier Management.
• Experience in Medical Device industry is preferred.
• 6 Sigma qualification an advantage.
• General knowledge of industry practices, techniques, and standards
• At ease working under general direction regarding the progress of projects and special assignments
• Excellent communication skills
• Working knowledge of Supplier interaction is an advantage.

What we can offer you:

• Comprehensive Benefits.
• Career Growth.
• Life - Work integration.
• The opportunity to make a difference in people’s lives.

If you are intersted in this job, please apply with a copy of your updated CV to Rebecca O'Connor at ROconnor@sigmar.ie 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine.  The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery.  Since 1994, employees in Galway have been at the forefront of some of these truly innovative medical device designs and manufacturing. 

Job Purpose

Provide scientific understanding and technical engineering skills to meet business goals and objectives. Ability to coach, lead and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports. Build collaborative relationships through strong teamwork across the organization.

Key Responsibilities

• Providing technical leadership on product and process issues.
• Leading technical improvement under the team’s VIP program.
• Transferring and implementing processes either from development or from another manufacturing facility.
• Liaison with quality and engineering both internal to the plant and externally within the corporation.
• Participation, where appropriate, in the phase review process and the NPE meetings with respect to new products.
• Ongoing manufacturing support in order to help the team meet its business objectives of quality, output and cost.
• Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital.
• Provide technical leadership/guidance for the Process Technician on the team (with specific responsibility to ensure that the preventative maintenance program is adequate and timely).
• Development and implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members.
• Project planning, in detail, in support of major projects, product/process transfer etc.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Responsible for other projects as assigned by the company.
• Demonstrate a primary commitment to patient safety and product quality.
• Understands and comply with all the regulations governing the quality systems
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
  

Qualifications

• NFQ Level 8 qualification (240 ECTS points) in engineering or a relevant field,
• Minimum of 2 years' relevant experience to include line support engineering.
• Medical Device or other highly regulated background highly desired.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Project Management experience desirable.

The Manufacturing Engineer will maximum the performance (quality; output volume & cost) of manufacturing processes, by providing high impact technical/operational support, and by developing processes to the highest possible standards.  They will co-ordinate and complete complex projects supporting the implementation of LEAN Manufacturing successfully against challenging timelines.

• Minimum of 5 years of professional experience in a responsible Manufacturing Engineering/ Process Development role within the Agri or similar industry.
• Six Sigma Green or Black Belt will have a significant advantage.
• Proven Implementation of Lean Manufacturing experience essential.
• Degree in Mechanical Engineering/Manufacturing Engineering.

• Implement appropriate process controls on to manufacturing processes for robust and repeatable commercial product manufacturing.
• Maximise manufacturing process performance through effective implementation of LEAN SIGMA methodology.
• Apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness and efficiency.
• Ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
• Support the development of new processes in conjunction with Process / Manufacturing / R&D Engineering ensuring that new processes are stable and capable.
• Provide adequate technical support to new product introductions and change controls are effectively managed.
• Ensure that non conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.
• Successfully complete validations and process improvements using statistical tools and six sigma techniques.
• Support the development of in-house Subject Matter Experts (SME) across the range of core technologies.