Project Manager

Curt Koland Recruiting is seeking candidates with a passion for delivering novel, game-changing technologies and who are committed to improving patient outcomes. Our client is a growth-stage medical device company that has developed, and is now commercial with, intelligently designed and engineered products. Experience in neurovascular, vascular or catheter device is preferred.~We are looking for candidates currently living in the San Francisco Bay Area with 5 or more years of experience in the Medical Device industry or a closely related field. Candidates must possess either US Work Authorization or US Citizenship. We are not able to accommodate H-1B Visa transfers at this time.~Job SummaryWe're looking for a highly motivated Project Manager to lead cross-functional initiatives supporting New Product Introduction (NPI), Product Lifecycle Management (PLM), and manufacturing improvement projects.This full-time role sits at the center of R&D, Quality, Regulatory, and Manufacturing, driving products from concept through commercialization in a fast-paced, collaborative environment.~What You'll DoLead cross-functional projects from development through commercial launchBuild and manage project plans, timelines, deliverables, and risk mitigation strategiesDrive design transfer activities from R&D into manufacturingCoordinate design control activities and maintain compliant product documentationSupport verification/validation, process qualification, and regulatory documentationPartner with suppliers and contract manufacturers to execute project objectivesTroubleshoot manufacturing challenges using root cause analysis and Six Sigma toolsEnsure compliance with FDA, ISO 13485, MDR, and global quality standards~QualificationsBachelor's degree in Engineering or related technical field (Master's preferred)5+ years of project management experience in medical device development and/or manufacturingExperience with catheter-based or neurovascular technologies preferred~Technical ExpertiseStrong knowledge of design controls, risk management, DV/IV, and regulated product developmentFamiliarity with FDA regulations, ISO 13485, MDR/MDD, and Quality Management SystemsExperience with process validation, DOE, SPC, and Six Sigma methodologiesWorking knowledge of CAD tools (SolidWorks preferred)Familiarity with EtO sterilization and ISO 10993 is a plus~What Makes You SuccessfulProven ability to lead cross-functional teams and drive executionStrong communicator with excellent organizational skillsHands-on problem solver who thrives in dynamic environmentsComfortable balancing technical detail with strategic project leadershipWillingness to travel occasionally to suppliers and manufacturing partners