Principal Manufacturing Engineer

Job Description Qualifications10+ years of experience in medical device manufacturing engineering, ideally in neurovascular or catheter-based technologiesExpertise in design controls, validation, process development, and documentation within a regulated environmentDeep understanding of FDA regulations, ISO 13485, MDD/MDR, and global QMS standardsStrong verbal/written communicator with the ability to influence across all levelsAgile problem-solver who thrives under pressure in dynamic environmentsResponsibilitiesYou'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 executedYou'll bring products from concept to commercial scale, helping accelerate time-to-market while upholding world-class quality standardsLead design-for-manufacturability (DFM) efforts for new neurovascular/vascular productsSpearhead design transfer activities, ensuring seamless handoff from R&D to productionDevelop and validate custom equipment, fixtures, and manufacturing processes that scalePartner with suppliers and contract manufacturers to source critical components and capabilitiesLead protocol development and execution for design verification, validation, and process qualificationTroubleshoot complex manufacturing issues and implement data-driven solutions using Six Sigma and root cause analysis toolsAuthor and maintain documentation that meets FDA, ISO 13485, and global regulatory requirementsDrive CAPA investigations, NC resolution, and continuous process improvement in productionAct as a cross-functional leader, collaborating with Quality, R&D, Operations, and Regulatory to launch high-impact medical productsTrack record of leading cross-functional projects from concept through commercializationWillingness to travel periodically to suppliers, partners, and contract manufacturers