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 deep technical expertise, be a strategic thinker, 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.
- Coordinate 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).