Senior Compliance Engineer, Medical & Electrical Safety
at Magic Leap, Inc.
Magic Leap’s mission is to harmonize people and technology to create a better, more unified world. Magic Leap is a team of creatives and technologists building a personal, spatial computing platform that seamlessly blends the digital and physical worlds. Magic Leap’s healthcare team is changing the world of healthcare professionals and is looking to expand its team.
The Senior Compliance Engineer will work closely with the R&D and Regulatory teams through the entire design process of new healthcare products to ensure the designs meet Medical Electrical Safety and country specific approvals.
Drive hardware and software development forward to meet key product milestones
Work closely with R&D engineers to communicate specifics requirements for compliance and ensure requirements are implemented
Review hardware designs for compliance to agency standards and recommend changes as needed
Submit product design to required agencies for approval, providing sample documentation as needed
Develop verification and validations plans in accordance with regulatory procedures, including IEC-62304, IEC-60601, IEC-62366, ISO-13485, and ISO-14971 standards
Provide input for technical manuals
Support internal and external audits as required
5+ years of experience in software engineering
Deep knowledge of IEC 60601 standards as they related to medical electrical equipment
Experience in Product Compliance, Technical Regulations and Standards
Experience working on projects involving a certified testing facility (e.g. UL, TUV, etc.) for MEE certification and/or CB Scheme purposes
Strong Project Management skills with the ability to support multiple projects
Experience working in a medical device industry
Experience working in a startup environment preferred
Education and/or Experience: Bachelor's degree from four-year college or university in Electrical or Mechanical Engineering or related field.
All your information will be kept confidential according to Equal Employment Opportunities guidelines.