We are looking for a strategic and hands-on Engineering Manager to lead manufacturing optimization, drive continuous improvement, and ensure the highest levels of product quality. This role is key in strengthening operational efficiency, guiding engineering teams, and supporting business growth through innovation and strong cross-functional collaboration within a highly regulated medical device manufacturing environment.
We are seeking a professional who combines strong technical expertise with leadership capability, a problem-solving mindset, and the ability to execute in a fast-paced, results-driven setting.
Required qualifications
- Bachelor’s degree in Mechanical, Industrial, or related Engineering
- 7+ years of experience in manufacturing (including leadership)
- Experience in catheter manufacturing processes (extrusion, assembly, bonding)
- Strong knowledge of Lean Manufacturing and continuous improvement
- Knowledge of GMP and manufacturing regulations
- Strong leadership and communication skills
- Bilingual (Spanish/English) preferred
Key responsibilities
- * Lead continuous improvement initiatives to optimize production and reduce costs
- * Ensure compliance with FDA, ISO 13485, and quality management systems
- * Manage engineering projects from concept to implementation
- * Oversee equipment selection, validation, and maintenance
- * Drive innovation and process enhancements within manufacturing
- * Coordinate cross-functional teams to meet project timelines and business goals
- * Develop and lead high-performing engineering teams
- * Maintain audit-ready documentation and support regulatory compliance
