10+ years of experience in medical device manufacturing engineering, ideally in neurovascular or catheter-based technologies
Expertise in design controls, validation, process development, and documentation within a regulated environment
Deep understanding of FDA regulations, ISO 13485, MDD/MDR, and global QMS standards
Strong verbal/written communicator with the ability to influence across all levels
Agile problem-solver who thrives under pressure in dynamic environments
Responsibilities
You’ll be a key technical leader, working at the intersection of R&D, quality, and production to ensure our breakthrough designs are scalable, cost-effective, and flawlessly executed
You’ll bring products from concept to commercial scale, helping accelerate time-to-market while upholding world-class quality standards
Lead design-for-manufacturability (DFM) efforts for new neurovascular/vascular products
Spearhead design transfer activities, ensuring seamless handoff from R&D to production
Develop and validate custom equipment, fixtures, and manufacturing processes that scale
Partner with suppliers and contract manufacturers to source critical components and capabilities
Lead protocol development and execution for design verification, validation, and process qualification
Troubleshoot complex manufacturing issues and implement data-driven solutions using Six Sigma and root cause analysis tools
Author and maintain documentation that meets FDA, ISO 13485, and global regulatory requirements
Drive CAPA investigations, NC resolution, and continuous process improvement in production
Act as a cross-functional leader, collaborating with Quality, R&D, Operations, and Regulatory to launch high-impact medical products
Track record of leading cross-functional projects from concept through commercialization
Willingness to travel periodically to suppliers, partners, and contract manufacturers