Lead Manufacturing Technician - Evening Shift

Edwards Lifesciences Gruppe; Limerick; On-site; EUR 65,000 - 85,000; Full time

Job summary

Edwards Lifesciences is seeking a Lead Technician to support Operations and Engineering in a medical device manufacturing environment. The role involves troubleshooting, maintenance, validation, and collaboration with QA and Engineering.

Working Hours : Monday to Thursday, 4:30pm-3am. You will lead projects, perform preventive maintenance, and support documentation control.

Qualifications

• Recognised trade or relevant third-level qualification with manufacturing/medical device exp.
• Minimum of 6 years related experience in manufacturing or engineering environments.
• Experience with validation, equipment maintenance, and documentation practices.

Responsibilities

• Troubleshoot and maintain equipment to limit downtime and support validation.
• Lead feasibility studies, tests, and reports for equipment and processes.
• Drive equipment validation projects and corrective actions with cross-functional teams.
• Perform preventive maintenance and drive documentation accuracy and compliance.
• Collaborate with QA, Engineering, and other departments to implement improvements.

Skills

Manufacturing experience

Engineering knowledge

Problem solving

Education

Trade qualification

Engineering degree

Tools

CAD

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.Our Lead Technician position is a unique career opportunity that could be your next step towards an exciting future.

The Lead Technician provides technical and function-specific knowledge to support Operations and Engineering activities. Working Hours : Monday to Thursday, 4:30pm-3am (Finish at 2am on Thursdays)

What You'll make an impact

• Troubleshoot and recommend maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance
• Design, set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review
• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time
• Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents
• Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs)
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
• Collaborate with Engineering and CAD/Designers to develop new basic tools
• Provide coaching and guidance to technicians
• Other incidental duties

What you'll need (Required):

• A recognised trade qualification or relevant third-level qualification, plus relevant manufacturing, engineering, or medical device industry experience; A minimum of 6 years of related experience.

What else we look for (Preferred):

• Strong written and verbal communication, interpersonal, and relationship building skills Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
• Strong computer skills, including usage of MS Office Suite; and CAD if applicable
• Full knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Knowledge of material compatibility in the proposed use environment
• Ability to understand the fundamentals of project management
• Full knowledge of routine preventive maintenance of production equipment
• Full knowledge electrical, mechanical, electronic, pneumatic, and controls
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Strict attention to detail
• Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.