Work Flexibility: Hybrid
Position Summary
The Senior Staff Engineer will drive a culture of automation, innovation, and continuous improvement to support the Neurovascular product portfolio. The engineer will have a deep technical expertise, be a strategic thinking, and have strong leadership capabilities to develop and implement solutions that enhance our operational efficiency and product quality.
The Engineer will work closely with cross-functional teams—including Manufacturing, R&D, Quality, and Regulatory Affairs—to deliver reliable, validated automation solutions that support scalability and compliance.
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 Areas of Responsibility
* 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.
* Be a Technological expert, willing to source, investigate and implement technological and automation advances.
* Lead design, development, testing & refinement of automated system, sub-system & component.
* Support the implementation of automation strategies across projects.
* Technical leadership of Staff engineers, Senior engineers, Engineers, Coop students, and Technicians.
* Co-ordinates with other unit's vendors and senior managers as needed to ensure specific cost, time, and regulatory standards achieved.
* Communicates with business partners to resolve process and product issues.
* Champion operations excellence across the site
Qualifications / Knowledge/ Skills
* Degree or Masters in relevant Engineering or Science discipline (Manufacturing, Mechanical, etc) or technical experience equivalency.
* Minimum of 6 years' experience.
* Recognised Lean qualification, ideally a black belt.
* Experience with medical device manufacturing processes (e.g., cleanroom automation, micro-assembly, automated testing).
* Technological expert, willing to source, investigate and implement technological and automation advances.
* Proven Project Management skills through the delivery of business-critical projects.
* Confident and effective decision maker, with a proven technical leadership ability to negotiate and influence others.
* Effective technical documentation and change control in regulated environments.
* Excellent cross-functional collaboration with Manufacturing, Quality, and R&D teams.
* Capable of technically leading a multi-disciplined team in a dynamic, regulated and results motivated environment.
* Demonstrable Excellent analytical & critical thinking skills, a process improvement orientation.
* Demonstrable ability to lead significant projects and initiatives.
* 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 (SolidWorks or similar).
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Travel Percentage: 10%