Manufacturing Engineer

About the JobOur mission at ClearPoint Neuro is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders. We are seeking a Manufacturing Engineer to support our manufacturing line at our Carlsbad, CA facility. The ideal candidate is highly driven, detail-oriented and has experience in the medical device field.Our team members are passionate about growth, innovation, collaboration and continuous improvement. We are constantly striving to improve and better ourselves so that we can better help patients and their families. If you have a growth mindset and thrive in a dynamic setting, you could be a great fit for our team!Company DescriptionClearPoint Neuro is a device, cell, and gene therapy-enabling company. We specialize in providing precise navigation to the brain and spine, offering both clinical products and pre-clinical development services for controlled drug and device delivery. With engagements in healthcare and research centers across North America, Europe, Asia, and South America, we are dedicated to improving and restoring the quality of life for patients and their families.Role DescriptionWe are seeking a Manufacturing Engineer for our Carlsbad, CA office who will be responsible for designing, optimizing and maintaining manufacturing processes, ensuring compliance with regulatory standards and driving continuous improvement initiatives. This role involves collaborating with cross-functional teams, troubleshooting production issues, and implementing process improvements to increase efficiency and product quality.Skills and QualificationsKnowledge of various manufacturing techniques common within medical device manufacturingUnderstanding of FDA regulations (21 CFR Part 820, ISO 13485), IEC 60601, and other industry standards specific to medical device manufacturing.Experience with Lean Manufacturing, Six Sigma methodologies and continuous improvement toolsProficiency with CAD software (SolidWorks) for designing fixtures, tooling, etc.Strong skills in statistical analysis using tools like Minitab for analyzing production dataStrong analytical and problem-solving skillsAbility to manage multiple projects, timelines, and cross-functional teamsExcellent written and verbal communication skillsStrong attention to detail and exceptional organizational skillsAbility to work independently, prioritize tasks, and meet deadlinesStrong team player, using both internal and external resources to execute activitiesDemonstrates ownership of results within (and beyond) area of responsibilityEnables and demonstrates the courage to speak up on issues and risksEducationBachelor's Degree in Engineering or related fieldLean Six Sigma Green Belt or Black Belt certification preferred but not required

Created: 2025-02-22