Job Title
We are seeking a Senior Manufacturing Engineer to drive innovation and excellence in our growing team.
This role involves developing and optimizing advanced manufacturing processes for Class II/III medical devices.
* Provide technical leadership and mentorship to engineers and technicians, ensuring stable, efficient, and compliant manufacturing operations.
* Lead complex troubleshooting efforts for equipment, tooling, process, or material issues using advanced problem-solving techniques.
* Drive continuous improvement initiatives using Lean, Six Sigma, and other structured methodologies.
* Own and oversee process and equipment change control activities, ensuring quality and regulatory compliance.
About the Role
In this position, you will have the opportunity to collaborate cross-functionally on new product introductions, risk management, and technology transfers.
You will represent manufacturing engineering in audits and regulatory inspections, ensuring compliance with international standards.
Requirements
To be successful in this position, you will need:
* A Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical or related discipline).
* 6–9 years' experience in medical device or pharmaceutical manufacturing, with proven leadership and mentoring responsibilities.
* Strong knowledge of medical device quality standards (ISO 13485, FDA QSR, EU MDR).