Manufacturing Excellence Opportunity
This role presents a key challenge in the development, optimization, and sustainment of manufacturing processes for advanced medical devices used in neurovascular treatments.
The position demands precision, process reliability and adherence to stringent regulatory and quality standards.
The successful candidate will be responsible for driving efficiency improvements across all stages of complex assembly operations ensuring validated systems consistently deliver exceptional product quality and operational excellence. Key responsibilities include owning and sustaining manufacturing processes within value streams ensuring product quality process stability and regulatory compliance. The individual must lead root cause analysis implement corrective actions address product and process issues. Identify opportunities for continuous improvement cost reduction projects applying Lean Six Sigma techniques execute equipment changes under our company's quality system including documentation risk assessment validation change control. Provide ongoing support with data collection analysis reporting on key performance metrics yield downtime cost per unit etc drive improvements based on findings. Support audits CAPA closure documentation updates ensure compliance with ISO 13485 FDA QSR standards train mentor technicians operators standard work best practices foster culture continuous improvement contribute cross-site collaboration share best practices lessons learned global manufacturing network.
Qualifications Knowledge & Skills
* Bachelor's degree (or equivalent) in Manufacturing Mechanical Industrial or Biomedical Engineering related discipline.
* Minimum 4+ years experience in manufacturing process engineering ideally regulated medical device high-volume precision assembly environment.
* Prolific expertise in Continuous Improvement Process Optimisation problem solving Lean Six Sigma Green Belt preferred strong understanding manufactured products validation change control processes solid knowledge CAPA management risk analysis PFMEA troubleshooting production challenges excellent interpersonal communication skills influence across functions technical judgment hands-on approach resolving intricate engineering dilemmas.