We are seeking an experienced Manufacturing Engineer to support our production processes for high-quality medical devices.
This role involves driving efficiency, ensuring compliance with regulatory standards, and supporting continuous improvement initiatives.
* Main Responsibilities:
* Develop, implement, and maintain manufacturing processes to meet production goals
* Support new product introductions and scale-up activities
* Troubleshoot and resolve manufacturing issues to minimize downtime
* Ensure compliance with ISO 13485, FDA, and GMP requirements
* Prepare and maintain process documentation, including work instructions and validation reports
* Lead continuous improvement projects using Lean and Six Sigma methodologies
* Collaborate with Quality, R&D, and Operations teams to ensure smooth production flow
Qualifications:
* Requirements & Qualifications:
* Bachelor's degree in engineering/technology discipline
* A minimum of 1-2 years' work experience in the Medical Devices / Pharmaceutical regulated industry
* Strong understanding of regulatory requirements and quality management systems
* Knowledge of change control processes and procedures
* Attention to detail
* Strong analytical and problem-solving skills