Device Assembly Process Engineer

AstraZeneca seeks a Device Assembly Process Engineer to lead assembly process development for medical devices and combination products, including prefilled syringes and auto-injectors. The role spans pilot laboratory operations, process characterization, design transfer activities, and regulatory support for biopharmaceutical manufacturing.

Responsibilities

• Provide technical leadership for fill-finish and assembly pilot laboratory operations including vial filling, syringe filling, lyophilization, and device assembly
• Conduct risk analyses and characterization studies on assembly methods to evaluate device performance parameters
• Design assembly process steps, establish operational design space, and develop control strategies
• Lead or support design transfer of assembly processes to contract manufacturers and internal facilities with multi-functional team coordination
• Support regulatory submissions, review batch records and validation protocols, and provide on-site troubleshooting for manufacturing operations

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related pharmaceutical science field; or Master's degree
• 5+ years of medical device or combination product development experience (with Bachelor's); or 2+ years (with Master's)
• Knowledge of biopharmaceutical development, cGMP regulations, and combination product assembly processes
• Proficiency in design of experiments, statistics, quality by design, and data analysis
• Experience with equipment validation, process validation, and design transfer
• Strong technical writing, leadership, and interpersonal communication skills

Compensation: $79,336.80 - $119,005.20 annual base