Senior/Staff Engineer, Pharmaceutical Delivery
AbCellera · Vancouver
Medical DeviceCompany career page
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Role summary
AbCellera seeks a Senior/Staff Engineer to lead pharmaceutical delivery device development for combination product programs including pre-filled syringes and autoinjectors. The role involves architecting design control frameworks, managing supplier partnerships, and ensuring drug-device integration across clinical and manufacturing stages.
What they're looking for
- 8+ years device engineering experience (6+ with Master's) for Senior; 12+ years (10+ with Master's) for Staff
- Direct experience with drug delivery systems, combination products, or parenteral devices
- Working knowledge of FDA Design Controls (21 CFR 820.30, 820.30) and relevant standards (ISO 13485, ISO 11608, ISO 14971, IEC 62366)
- Demonstrated ability to manage external device partners and CDMOs with technical authority
- Familiarity with Human Factors Engineering principles and user research integration
- Experience with distribution and transport simulation studies for parenteral products
What you'll be doing
- Drive delivery device strategy and execution across drug-device combination programs
- Lead Design History File creation and develop design controls from user needs to product specifications
- Develop and implement Human Factors program including formative studies, summative validation, and Instructions for Use
- Conduct gap analysis assessments to de-risk manufacturing scale-up and confirm critical attribute compliance
- Own drug-device interface alignment between formulation, container closure, and device design inputs
Privacy & handoff
This role links to AbCellera's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.