Senior Staff Engineer Position
We are seeking a Senior Staff Engineer to lead our manufacturing engineering team. This role will drive innovation and continuous improvement, supporting our Neurovascular product portfolio.
Key Responsibilities:
* Oversee automation projects from conception to execution.
* Contribute to the engineering functional strategy.
* Collaborate with cross-functional teams to identify automation opportunities.
* Lead design, development, testing & refinement of automated systems.
* Support the implementation of automation strategies across projects.
* Provide technical leadership to staff engineers, senior engineers, engineers, coop students, and technicians.
Requirements:
* Relevant degree or master's in an engineering or science discipline (Manufacturing, Mechanical, etc).
* Minimum 6 years' experience.
* Recognized Lean qualification, ideally a black belt.
* Experience with medical device manufacturing processes.
* Proven project management skills.
Tech Skills:
* CAD tools for fixture and tooling design (Solid Works or similar).
* Integration of MES/ERP systems for manufacturing data traceability.
* 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.