Senior Engineer, Combination Products & Device Development

AbCellera is hiring a Senior Engineer, Combination Products & Device Development to advance its prefilled syringe and autoinjector combination product programs. The role executes design controls, translates user and product needs into technical requirements, and works with device suppliers and CDMOs to move products toward clinical and commercial readiness — covering Design History File documentation, device/combination product risk management, Human Factors programs, technology transfer and packaging/distribution evaluation, and authoring device-related content for regulatory submissions (INDs, CTAs/IMPDs, BLAs, MAAs). Candidates need 8+ years of direct experience in drug delivery systems and combination products (prefilled syringes, autoinjectors, or needle safety systems preferred) from a mechanical, biomedical, or chemical engineering background, working knowledge of FDA Design Controls and combination product quality requirements (21 CFR Parts 4 and 820, ISO 13485/11608/11040/14971, IEC 62366), and experience managing external device partners and CDMOs. This is a Vancouver-based role; AbCellera's posted hiring range is CAD $116,000-$145,000 annually plus equity, bonus, and RRSP contribution.