Senior Staff Engineer, Manufacturing Engineering
The Senior Staff Engineer will drive a culture of automation, innovation, and continuous improvement to support the Neurovascular product portfolio.
This position requires both hands-on technical expertise and strong project management skills to bring innovative automation solutions from concept to production within a highly regulated environment.
Key Responsibilities:
* Oversee automation projects from conception to execution, ensuring alignment with organizational goals.
* Contribute and input into Engineering functional strategy.
* Collaborate with cross-functional teams to identify automation opportunities and prioritize initiatives.
* Lead design, development, testing & refinement of automated system, sub-system & component.
* Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
* Support the implementation of automation strategies across projects.
* Technical leadership of Staff engineers, Senior engineers, Engineers, Coop students, and Technicians.
Requirements:
* Qualifications: Level 8 Degree or Masters in relevant Engineering or Science discipline (Manufacturing, Mechanical, etc) or technical experience equivalency.
* Experience: Minimum of 6 years' experience.
* Skillset: Recognised Lean qualification, ideally a black belt. Experience with medical device manufacturing processes (e.g., cleanroom automation, micro-assembly, automated testing).
About this role:
* Demonstrable Excellent analytical & critical thinking skills, a process improvement orientation.
* Familiarity with GAMP 5 and computer system validation (CSV) for automated equipment.
* Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 11 compliance in automation systems.
* Experience with integration of MES/ERP systems for manufacturing data traceability.
* Proficient in CAD tools for fixture and tooling design (Solid Works or similar).