Senior Engineer I, Device Development

Responsibilities

• Act as a technical Subject Matter Expert (SME) for the development of combination products, including pre-filled syringes, autoinjectors, and on-body delivery systems.
• Manage technical design deliverables such as critical dimension identification, systems engineering, sensitivity analysis, and tolerance stack-ups.
• Oversee characterization and design verification testing, including method development, qualification, and transfer.
• Author technical documentation in support of the design control process.
• Perform root cause analysis of product or process deviations using Six Sigma tools.
• Collaborate with cross-functional teams including Device Quality, Regulatory Affairs, Clinical, and Global Technical Operations.

Requirements

• BS degree in Mechanical, Biomedical, Chemical, or Materials Science Engineering (or closely related discipline).
• 6+ years of product design/development experience in the medical device or pharmaceutical industries.
• Demonstrated experience with all phases of the Design Control process.
• Strong understanding of medical device risk management methodologies.
• Proficiency in statistical analysis tools (e.g., Minitab, Crystal Ball) and analytical tools (e.g., FEA).
• Knowledge of regulatory compliance requirements (FDA, ISO, IEC) for medical devices and combination products.

Preferred Qualifications

• Master’s or PhD degree in an Engineering discipline.
• 6-10+ years of experience in medical device/container closure development.
• 2+ years of experience specifically in combination product commercialization.

About the Company

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. Through our Alexion Device Development organization, we strive to deliver innovative combination products that improve patient outcomes worldwide.