Serve as Development Engineer within the Alexion Device Development organization
Act as the technical SME/project engineer supporting the development of combination products
Interact with multiple functions and functional teams including Device Quality, Regulatory Affairs, Clinical, and Global Technical Operations
Responsible for key technical design and development deliverables
Oversee characterization and design verification testing as well as determine relevant success criteria
Author technical documentation in support of the development process or design control deliverables
Conduct root cause analysis of product or process deviations or failures
Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation

6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries
Experience with developing products or implementing product changes through a structured, phase-gated, product development process
Demonstrated experience with all phases of the Design Control process
Understanding of medical device product development risk management methodologies
Possesses expertise in statistical analysis (Minitab, Crystal Ball, etc), analytical tools (e.g. FEA), and benchtop testing (e.g. Zwick, fixture design)
Knowledge of performance and regulatory compliance (EU and FDA) requirements of medical device and combination products
Bachelor, Master’s, or PhD Degree in Engineering (Mechanical, Biomedical, Chemical or Materials Science and Engineering) or closely related disciplines preferred.
6-10 years’ experience in medical device/container closure development with 2+ years in combination product commercialization

Senior Engineer I, Device Development

Key skills