Senior Staff Engineer, Manufacturing Engineering

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. 

• Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation. 

• Observing the Quality Management Systems requirements on site at all times 

• 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 

• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site.  

 

 

 

 

Qualifications  / Knowledge /​ Skills  

 

• Level 8 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). 

 

#IJ

Travel Percentage: 10%