Join us as a Device Engineer within our Global Technical Operations team! You will be part of the team accountable for commercial device technologies and combination products, maintaining the Design History File throughout the product life-cycle for commercial devices and combination products.
This position is a corporate global role supporting multiple manufacturing sites, working closely with the combination product team members, device development group, and manufacturing sites to ensure smooth and seamless design transfer for combination product pipeline projects and life-cycle management of commercial combination products.
What you will do:
Engage in design control activities with the development team and manufacturing sites for new combination product introduction.
Support Device Responsible Persons (DRPs) for Design History File (DHF) management through the life cycle including changes to on-market products.
Complete risk management activities for the on-market combination products including maintenance of Risk Management Documents (e.g. FMEAs), and conduct periodic risk reviews based on ISO 14971.
Minimum Qualifications:
Bachelor's degree in Mechanical, chemical, or biomedical engineering or related engineering/scientific field with less than a year of industrial experience.
Understanding OR knowledge of combination product, device development, and characterization including assembly processes, human factors, design controls, risk management, and organizational change.
Procedures and compliance with Good Manufacturing Practices (GMPs) and Safety, Health, and Environment requirements knowledge.
Preferred Qualifications:
Knowledge of development and life-cycle management of injectable combination products.
Experience supporting on-market biological combination products is a plus.
Knowledge of statistics like control charting, capability analysis, Lean Six Sigma, and other problem-solving techniques.
Experience with basic (e.g. Word, Excel, and PowerPoint) and drawing (e.g. Solidworks) software.
Broad understanding of biopharmaceutical development from late-stage development through commercial life-cycle management.
At AstraZeneca, we are passionate about new products and launches. We work with innovative and scientific products on our groundbreaking end-to-end supply chain, using the latest technologies and modern facilities. We are active players in growth and evolution. It's a clear long-term strategy, and we see our role. There's an excellent opportunity to influence how we develop supply chains, promoting a Lean attitude and leading on sustainability.
Are you ready to accept constant challenges? For us, they are intellectually stimulating opportunities to learn more. A chance to come back stronger and eager for more. We keep pushing the boundaries as we work on implementing the best systems with cutting-edge science and manufacturing.
Apply now to be part of our Operations team!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.