Project Manager

Project Manager at Curt Koland, Inc. Project Manager at Curt Koland, Inc. in San Leandro, California Posted in 1 day ago.

Type:

full-time

Job Description:

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 Summary We'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 Do Lead cross-functional projects from development through commercial launch Build and manage project plans, timelines, deliverables, and risk mitigation strategies Drive design transfer activities from R D into manufacturing Coordinate design control activities and maintain compliant product documentation Support verification/validation, process qualification, and regulatory documentation Partner with suppliers and contract manufacturers to execute project objectives Troubleshoot manufacturing challenges using root cause analysis and Six Sigma tools Ensure compliance with

FDA, ISO

13485, MDR, and global quality standards ~ Qualifications Bachelor's degree in Engineering or related technical field (Master's preferred) 5+ years of project management experience in medical device development and/or manufacturing Experience with catheter-based or neurovascular technologies preferred ~ Technical Expertise Strong knowledge of design controls, risk management, DV/IV, and regulated product development Familiarity with FDA regulations, ISO 13485, MDR/MDD, and Quality Management Systems Experience with process validation, DOE, SPC, and Six Sigma methodologies Working knowledge of CAD tools (SolidWorks preferred) Familiarity with EtO sterilization and

ISO 10993

is a plus ~ What Makes You Successful Proven ability to lead cross-functional teams and drive execution Strong communicator with excellent organizational skills Hands-on problem solver who thrives in dynamic environments Comfortable balancing technical detail with strategic project leadership Willingness to travel occasionally to suppliers and manufacturing partners