Manufacturing Engineer Role Overview
This position involves leading and sustaining manufacturing processes within value streams for Neurovascular products. Key responsibilities include ensuring product quality, process stability, and regulatory compliance.
The successful candidate will lead root cause analysis and implement corrective actions to address product and process issues. Additionally, they will identify and deliver continuous improvement (CI) and cost reduction projects focused on OEE, yield, and scrap reduction. These initiatives will be implemented using Lean, Six Sigma, and statistical techniques.
The Manufacturing Engineer will execute process and equipment changes under a quality system, including documentation, risk assessment, validation, and change control. This role also supports ongoing process validation (IQ/OQ/PQ) and maintains a validated state through periodic reviews and revalidations as required.
The ideal candidate will partner with Production, Quality, Maintenance, and Supply Chain teams to improve equipment uptime, throughput, and reliability. They will lead data collection, analysis, and reporting on key performance metrics (yield, downtime, cost per unit, etc.) and drive improvements based on findings.
They will support and lead audits, CAPA closure, and documentation updates to ensure compliance with ISO 13485 and FDA QSR standards. Furthermore, the Manufacturing Engineer will train and mentor technicians and operators on process changes, standard work, and best practices to foster a culture of continuous improvement.
Key Qualifications
* Bachelor's degree in Manufacturing, Mechanical, Industrial, or Biomedical Engineering (or related discipline).
* Minimum 4+ years of experience in manufacturing or process engineering, ideally in a regulated medical device or high-volume precision assembly environment.
* Proven expertise in continuous improvement, process optimization, and problem-solving (Lean/Six Sigma Green Belt preferred).
* Strong understanding of manufacturing documentation, change control, and validation processes.
* Solid experience with CAPA management, risk analysis (PFMEA), and troubleshooting production issues.
* Excellent interpersonal and communication skills with the ability to influence and work cross-functionally.
* Strong technical judgment and a hands-on approach to resolving complex engineering challenges.