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.
Your Role
Reporting to the Head of the Product Industrialization group, the Device Development Engineer is responsible for developing, validating, and integrating robust device manufacturing processes at the Cork site for new products used in Pharmaceutical and Biotechnology industries. The candidate will collaborate with R&D leads in North America and Europe to ensure process development excellence and meet project milestones.
Responsibilities
1. Drive development and integration of new device manufacturing processes at Cork, following the stage gate product development process.
2. Collaborate with Engineering & Technology to develop URSs for new equipment, participate in equipment design, control philosophy, and HAZOP evaluations.
3. Participate in FAT and IQ/OQ/PQ of new equipment, ensuring project budgets and schedules are maintained.
4. Represent R&D projects at Cork, liaising with cross-functional teams to meet project milestones.
5. Support manufacturing trials, communicate trial plans, and guide operators to meet objectives.
6. Design processes for manufacturing, automation, cost-effectiveness, and compliance with Quality and EHS standards.
7. Lead change controls for new processes and equipment upgrades.
8. Develop documentation and method statements for new processes to ensure readiness and robustness.
9. Monitor and improve R&D processes from operational, quality, and EHS perspectives.
10. Ensure new process development does not impact existing commercial processes.
11. Coordinate digitization of trial data, improve testing methods, and train operators.
12. Create draft BOMs and liaise with finance for product costing.
Qualifications
• Bachelor’s in engineering/science with 3-5 years of related experience, or MS with 3 years, or PhD with 0-3 years.
• Strong engineering problem-solving skills, experiment design, data analysis, and communication abilities.
• Ability to interpret data and make decisions under pressure.
• Effective planning and organizational skills.
• Knowledge of laboratory and manufacturing safety practices.
• Desirable: experience in process validation, automated assembly equipment, injection molding, high-precision tools.
• Detail-oriented, capable of executing trial plans and coordinating testing.
• Understanding of manufacturing equipment and controls.
• Familiarity with GMP environments.
• Knowledge of Minitab, AutoCAD, SolidWorks is a plus.
What We Offer
We celebrate diversity and believe it drives innovation and progress. We are committed to creating inclusive opportunities for all and empowering you to achieve your ambitions. Join us in building a culture of inclusion that impacts millions and fosters curiosity and growth!
#J-18808-Ljbffr