Combination Product Device Engineer

AbCellera Biologics Inc.

Drive combination product engineering at AbCellera, translating formulation constraints into device inputs for pre-filled syringes and autoinjectors. Apply rigorous technical judgment.As a Senior/Staff Engineer, Pharmaceutical Delivery, you will own the drug-device interface across development programs. You will align Process Development with device requirements while partnering with Quality, Regulatory, Formulation, and Drug Product teams. Your work connects design intent with manufactured reality.Key Responsibilities:
Own drug-device interfaces and define precise design inputsTranslate user needs into product specifications and trace matricesLead packaging and shipping evaluations for device integrityIntegrate design reviews and freeze milestones into timelinesAuthor device sections for IND and CTA submissionsRequirements:
Hands-on pharmaceutical delivery device engineering experiencePrefilled syringe, autoinjector, or safety system experience preferredKnowledge of ISO 13485, ISO 11608, and ISO 14971Experience integrating user research into device controlsStrong cross-functional communication and attention to detailUse drug-device interface expertise, regulatory knowledge, and technical execution to advance AbCellera combination products toward clinical assembly.
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