Senior Staff Engineer, Manufacturing Engineering
Senior Staff Engineer, Manufacturing Engineering
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Job Description
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 teamsincluding Manufacturing R&D Quality and Regulatory Affairsto 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 units 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
Required Experience:
Staff IC
Employment Type
Full-Time
