Development Engineer

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. This involves following the stage gate product development process to release new products to manufacturing.
• Work closely with the Engineering & Technology group to develop URSs for new process equipment and contribute towards equipment design, control philosophy, HAZOP evaluations, etc.
• Participate in FAT and IQ/OQ/PQ of the new equipment and ensure capital project budget and schedule are maintained.
• Represent R&D projects at the Cork site liaising with cross functional teams comprised of R&D, Operations, Quality, EHS, Engineering, Procurement, Supply Chain and Project Management to ensure that project milestones and dates are met to the satisfaction of all functions.
• Support the running of trials in the manufacturing plant via communication of trial plans to the operations team and directing operators on the floor to ensure that trial objectives are met.
• Ensure new processes are designed for manufacture, automated, innovative, cost effective and meet all Quality and EHS regulatory requirements
• Lead change controls for the introduction of new processes, new equipment, and equipment upgrades.
• Develop documentation for new processes in collaboration with site functions to ensure readiness and robustness of processes prior to release to manufacturing. Produce method statements for all new operational tasks.
• Monitor R&D processes through their development continuously improving control from an operational, quality and EHS perspective where possible
• Ensure the development of new processes in Cork has no impact on existing commercial processes, when applicable.
• Co-ordinate the digitization of trial data ensuring validity of results. Identify improvements of test methods and lead training with operators to ensure unified approaches are implemented across all operators/technicians
• Create draft BOM's for processes and liaising with the ISCO financial controller to enable product costing

• A Bachelor’s in engineering/science or equivalent plus 3-5 years of experience in a related technical area or MS plus 3 years or PhD plus 0-3 years.
• The successful candidate must be competent in engineering methods and problem solving with the proven ability to design and execute experiments, analyze data, formulate conclusions, and communicate findings in both an oral and written format.
• Can quickly interpret data and can apply his/her interpretations to make key decisions under pressure.
• Effective planning and organizational skills are required.
• Knowledge of laboratory and manufacturing safety practices are needed.
• Knowledge and experience in process validation, automated/ Semi-Automated assembly equipment, injection moulding and mould tools, High precision punch & die sets would be desirable.
• The individual must be detail-oriented and will be responsible for executing trial plans including coordination of testing/evaluation of trial material.
• Has a good understanding of manufacturing equipment and controls.
• Familiar working in a GMP/regulated environment.
• Knowledge of Minitab, AutoCAD, Solidworks is desirable.

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!