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Senior Compliance Engineer, Medical & Electrical Safety

Magic Leap, Inc., Plantation, FL

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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.

Job Description

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.

Responsibilities

  • 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

Qualifications

  • 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

  • Education and/or Experience: Bachelor's degree from four-year college or university in Electrical or Mechanical Engineering or related field.

Additional Information

  • All your information will be kept confidential according to Equal Employment Opportunities guidelines.

 

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About Magic Leap, Inc.

How It All Began October 5, 2017 Today, Magic Leap is a company made up of hundreds of artists, engineers, explorers, and dreamers from around the globe, all chasing their curiosity toward the same goal – bringing together the digital and real worlds to advance human potential. But it all began on a road trip to Austin when we asked the question – “what if computing could spill outside the computer?”

Want to learn more about Magic Leap, Inc.? Visit Magic Leap, Inc.'s website.