Senior Engineer, Combination Products & Device Development

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are looking for a Senior Engineer, Combination Products & Device Development to play a key technical role in advancing our combination product programs, including prefilled syringes and autoinjectors. In this role, you’ll execute design controls, translate user and product needs into technical requirements, and work with device suppliers and contract development and manufacturing organizations (CDMOs) to drive products toward clinical and commercial readiness. You’ll work closely with Quality, Regulatory, Formulation, and Drug Product teams, bringing together device engineering and biologics development to shape how our antibody therapies are delivered to patients. H ow you might spend your days Developing and maintaining Design History File documentation, translating user needs into design input and product requirements, and supporting design controls, design outputs, verification and validation, traceability, and design reviews throughout the product lifecycle Executing device and combination product risk management activities, including development and maintenance of risk analyses and ensuring appropriate linkage among product requirements, risk controls, verification and validation activities, and device performance requirements Supporting Human Factors (HF) programs, from formative studies through summative validation, including development Instructions for Use (IFU), device labelling content, and associated HF engineering documentation Conducting technical gap assessments and supporting technology transfer and scale-up activities to confirm that fill-finish, device assembly, and packaging operations can consistently meet applicable input requirements, Essential Drug Delivery Outputs (EDDOs) and other critical attributes Managing and supporting external technical partnerships with device component suppliers, CDMOs, testing laboratories, and consultants, providing technical oversight of project scope, work packages, deliverables, timelines, and development activities Developing and executing packaging, shipping, and distribution evaluation strategies for prefilled syringes and autoinjectors to assess EDDOs, container closure integrity, and product quality throughout distribution Partnering with Quality Assurance to develop, review, and maintain medical device and combination product QMS procedures, and supporting supplier controls, Quality Agreements, and other QMS activities Partnering with Regulatory Affairs to support device regulatory strategy and author device-related documentation for clinical and commercial submissions, including INDs, CTAs/IMPDs, BLAs, and MAAs, as programs advance through development W e’d love to hear from you if You bring…