Engineering Technician

Recruitment by Aphex; Waterford; On-site; EUR 52,000 - 78,000; Full time

Job summary

Recruitment by Aphex is seeking a capable Manufacturing Engineer for a medical manufacturing environment in Ireland. The role focuses on supporting quality and validation within the Company’s management systems, while developing and maintaining manufacturing processes and equipment.

You will evaluate processes, design testing methods, and contribute to continuous improvement through faultfinding and leadership in technical issue resolution.

Qualifications

• Ordinary Degree (Level 7) in Engineering or Technical Science.
• 3+ years’ experience in a medical manufacturing environment.
• Knowledge of ISO, FDA, GMP and Six Sigma.
• Strong interpersonal, self-presentation and communication skills.
• Sound faultfinding methodology and problem-solving ability.
• Ability to lead in resolving technical issues.
• Understanding of validation processes and regulated environments.
• Strong leadership and team collaboration.
• Commitment to quality, customer satisfaction and continual improvement.

Responsibilities

• Support the quality of the manufacturing and validation processes through the Company's management systems: Quality, HR, OHS.
• Develop and maintain manufacturing processes by analysing product requirements, researching, designing, modifying, and testing manufacturing methods and equipment.
• Evaluate processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
• Assure product and process quality by designing testing methods, testing finished product and process capabilities, establishing standards, confirming manufacturing process.
• Improve manufacturing efficiency by analysing and planning work flow, space requirements and equipment layout.
• Develop manufacturing technical capabilities and skills to ensure ongoing process requirements can be effectively achieved and continually improved.

Skills

Interpersonal communication

Leadership

Problem solving

Quality mindset

Team collaboration

Education

Ordinary Degree (Level 7) in Engineering or Technical Science

Job description

• Support the quality of the manufacturing and validation processes through the Company's management systems: Quality, HR, OHS.
• Develop and maintain manufacturing processes by analysing product requirements, researching, designing, modifying, and testing manufacturing methods and equipment.
• Evaluate processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
• Assure product and process quality by designing testing methods, testing finished product and process capabilities, establishing standards, confirming manufacturing process.
• Improve manufacturing efficiency by analysing and planning work flow, space requirements and equipment layout.
• Develop manufacturing technical capabilities and skills to ensure ongoing process requirements can be effectively achieved and continually improved.
• Provide manufacturing decision making information by identifying cost saving initiatives in labour and material costs and consumption and process improvements.
• Keep equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures.
• Prepare technical documentation such as SOPs, safety programmes, validation protocols, technical reports, engineering calculations, change controls and other documentation as required.
• Maintain and present when required appropriate technical data to internal / external audit and inspection groups and Customers.
• Be a member of the cross-functional team responsible for ensuring that all Customer requirements are consistently being achieved and/or exceeded.
• Be flexible in supporting the production process and third party contractors to meet the business and facility needs.
• Report to Plant Manager or designated representative.

Requirements

• Ordinary Degree (Level 7) in Engineering or Technical Science.
• Previous experience in a medical manufacturing environment (ideally 3+years).
• Knowledge of ISO, FDA, GMP and six sigma requirements.
• Professional interpersonal, self-presentation and communication skills.
• Demonstrate sound methodology in faultfinding techniques.
• Capability to take the lead in resolving technical issues.
• Understanding of Validation processes and regulated environments.
• Strong leadership skills with ability to motivate and direct.
• Positive team working approach and adherence to Policies and Procedures.
• Focus on Quality, Customer Satisfaction and continual improvement.