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 Product Industrialization group, the Device Development Engineer is primarily responsible for the development, validation, and integration of robust device manufacturing processes at the Cork site for new and innovative products used in Pharmaceutical, Biotechnology industries. The candidate will work closely with Downstream R&D leads in North America and Europe to drive excellence in process development and aggressively pursue project milestone dates.
Duties & Responsibilities
* Work as a key member of the Product Industrialization team to drive the development and integration of robust new device manufacturing processes at the Cork site, following the stage gate product development process to release new products to manufacturing.
* Collaborate with the Engineering & Technology group to develop URSs for new process equipment, contribute to equipment design, control philosophy, HAZOP evaluations, etc.
* Participate in FAT and IQ/OQ/PQ of new equipment, ensuring project budgets and schedules are maintained.
* Represent R&D projects at the Cork site, liaising with cross-functional teams to meet project milestones and deadlines.
* Support manufacturing trials by communicating trial plans and directing operators to ensure objectives are met.
* Design processes for manufacture that are automated, innovative, cost-effective, and compliant with Quality and EHS regulations.
* Lead change controls for new processes, equipment, and upgrades.
* Develop documentation for new processes, ensuring readiness and robustness before release to manufacturing, including method statements.
* Monitor R&D processes, continuously improving control from operational, quality, and EHS perspectives.
* Ensure new processes do not impact existing commercial processes when applicable.
* Coordinate digitization of trial data, improve test methods, and lead training to ensure standardized approaches.
* Create draft BOMs for processes and liaise with the financial team for product costing.
Who You Are
* Bachelor’s in engineering/science or equivalent plus 3-5 years of related experience, MS plus 3 years, or PhD plus 0-3 years.
* Proficient in engineering methods, problem-solving, experiment design, data analysis, and communication.
* Ability to interpret data quickly and make decisions under pressure.
* Strong planning and organizational skills.
* Knowledge of laboratory and manufacturing safety practices.
* Experience in process validation, automated/semi-automated equipment, injection molding, high-precision tooling is desirable.
* Detail-oriented with experience executing trial plans and coordinating testing.
* Understanding of manufacturing equipment and controls.
* Familiarity with GMP/regulatory environments.
* Knowledge of Minitab, AutoCAD, SolidWorks is a plus.
What we offer: We are curious minds from diverse backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity, believing it drives excellence and innovation. We care about our customers, patients, and our diverse team. This diversity strengthens our leadership in science and technology. We are committed to inclusion and belonging, empowering you to fulfill your ambitions. Join us in building a culture of inclusion that impacts millions and enables everyone to bring their curiosity to life!
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