Manufacturing Technician

About the Role

We are seeking a Manufacturing Technician to join our team in Galway, supporting day-to-day production operations. This role is essential in ensuring efficient, compliant manufacturing of advanced medical devices following International Standards such as ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulation (MDR), and the Vivasure Medical Quality Management System.

Key Responsibilities

• Provide technical assistance on the production line to maintain smooth and effective operations.
• Respond swiftly to manufacturing interruptions or irregularities to minimise downtime.
• Diagnose and solve issues linked to equipment, tooling, processes, or materials.
• Set up and operate manufacturing machinery, ensuring devices are used correctly and function properly.
• Conduct routine and preventive maintenance on production equipment to uphold performance.
• Identify opportunities and apply improvements to manufacturing processes, including tools, jigs, and methods, enhancing product quality and efficiency.
• Utilise Lean, Six Sigma, or other continuous improvement techniques to reduce waste and inefficiencies.
• Engage in development activities for both new and existing product processes.
• Support verification and validation testing of equipment, processes, and products.
• Accurately maintain batch documentation, logs, check sheets, and maintenance records in line with GMP and quality requirements.
• Perform or assist with in-process inspections, functional tests, and investigations into non-conformances.
• Maintain detailed technical documentation conforming with Quality Management System standards.
• Provide input during risk assessments and Failure Modes and Effects Analysis (FMEA).
• Collaborate with cross-functional teams for line validations, engineering builds, and product transfers.
• Assist in training product builders on processes and work instructions.
• Participate in root cause analyses and implement corrective and preventive actions as part of the manufacturing team.
• Keep equipment, workspaces, and facilities clean and safe, ensuring compliance with good manufacturing practices.

Qualifications & Experience

• A third-level qualification in a relevant technical discipline is preferred.
• 2 to 5 years of practical experience within the medical device or pharmaceutical manufacturing environment.
• Hands-on experience with operating and maintaining production equipment.
• Familiarity with process improvement initiatives.
• Knowledgeable in Quality Management Systems and regulatory requirements applicable to the medical device sector.

Key Skills & Abilities

• Strong communication and organisational capabilities.
• Effective teamwork skills and an ability to work independently when needed.
• Proficient in Good Documentation Practices and experienced with Microsoft Office suite (Word, Excel, PowerPoint).
• Understanding of cleanroom manufacturing processes and related methodologies.
• Ability to interpret technical drawings, process flow diagrams, and equipment manuals.

Compensation

Annual salary range is €37,100 to €50,300, depending on location, qualifications, experience, and skills. Additional compensation may include discretionary bonuses, sales incentives where applicable, and potential participation in long-term incentive plans. The company provides a comprehensive benefits package.

Additional Information

If eligible, detailed compensation and benefits information is available upon request via the company HR department.