Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
Reporting to the Process & Technology Manager, the Process & Technology Engineer is primarily responsible for supporting the development and introduction of new products within the Biotools manufacturing areas and effectively implementing change management projects.
Duties:
1. Process Engineering lead for new product introduction to Cork Manufacturing Operations, Project Management lead depending on project responsibilities, scope and complexity.
2. Provides Manufacturing support for new R&D products from Concept to Production (Product Development Procedure), is an active team member who contributes to the development of new concepts, processes and products. Co-ordinates inputs from Cork Manufacturing for Preliminary Investigation, Detailed Investigation, Product Development & Validation.
3. Conduct feasibility trials/process DOE’s to determine appropriate/robust process windows.
4. Ensures new processes are designed for manufacture, automated, innovative, cost effective and meet all Quality and EHS regulatory requirements.
5. Prepares Manufacturing product cost estimates under guidance.
6. Initiates equipment and mould User Requirement Specifications, vendor selection, requests for quotation and equipment/mould build, management of same depends on project responsibilities, scope and complexity.
7. Manages and executes the production equipment transfer into Cork, takes a hands-on lead role in activities required to achieve Commercialization:
1. Installation – executes IQ & OQ.
2. Completes training – Engineers, technicians and operators.
3. Documentation – drafts and executes validation protocols under guidance from QA, SOPs etc.
4. Trouble shooting & problem solving.
5. Demonstrates Manufacturability.
6. Executes PQ under guidance from QA.
8. Supports production, process optimization, scale up production and handover to production.
9. Ensure compliance with GMP and Safety requirements on new and existing equipment.
10. Maintain and develop manufacturing process documentation and procedures. All process changes and modifications to be documented and tracked closely.
Who You Are
1. Bachelor’s degree in Mechanical / Biomedical/ Process Engineering or similar.
2. Minimum 3 – 5 years engineering experience in Manufacturing, Moulding, New Product Introduction or Product Development in the Medical Device or similar regulated industry.
3. Working Knowledge of the following would be an advantage but not a requirement:
1. Automated / Semi Automated assembly equipment.
2. Injection moulding and mould tools.
3. High precision Punch & Die Sets.
4. Heat sealing, ultrasonic welding, leak testing, vision systems.
5. OEE Line performance methodology.
6. Minitab/ Lean 6 Sigma techniques.
7. AutoCAD.
4. Excellent verbal, written & interpersonal communication skills.
5. Process driven and experienced in standardizing and simplifying work processes.
6. Leadership & Influencing Skills.
7. Excellent engineering ability.
8. Good stakeholder management skills across all levels.
9. Experience in working in a complex matrix organization.
10. Team Orientated.
11. Demonstrate a high level of responsiveness to internal customers (e.g., production).
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
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