What are the responsibilities and job description for the Manufacturing Engineer position at ClearPoint Neuro, Inc.?
About the Job
Our 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 Description
ClearPoint 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 Description
We 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 Qualifications
- Knowledge of various manufacturing techniques common within medical device manufacturing
- Understanding 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 tools
- Proficiency with CAD software (SolidWorks) for designing fixtures, tooling, etc.
- Strong skills in statistical analysis using tools like Minitab for analyzing production data
- Strong analytical and problem-solving skills
- Ability to manage multiple projects, timelines, and cross-functional teams
- Excellent written and verbal communication skills
- Strong attention to detail and exceptional organizational skills
- Ability to work independently, prioritize tasks, and meet deadlines
- Strong team player, using both internal and external resources to execute activities
- Demonstrates ownership of results within (and beyond) area of responsibility
- Enables and demonstrates the courage to speak up on issues and risks
Education
