Lead Regulatory Engineer - Electrical (Medical and Enterprise)
at Magic Leap, Inc.
The Lead Regulatory Engineer - Electricalwill be responsible for ensuring that Magic Leap’s products (ML device, batteries and chargers, etc) meet all applicable electrical regulatory requirements for Enterprise and Medtech market launch and throughout the product life cycle. You will work closely with Regulatory Bodies, Test Labs, Product Design Teams, Supply chain and Electrical Engineers to ensure Magic Leap’s products are in full compliance.
Identify applicable electrical regulatory requirements and provide technical translation of requirements to Engineering teams as required
Work with Quality Assurance and Engineering teams to implement requirements into product definition
Interface with Test labs and internal teams to develop required test plans
Oversee and support all external electrical testing at test labs as required
Prepare and review documentation for test labs, notified body and other governing regulatory bodies.
Review and critique test reports generated by test labs
Create processes as needed to ensure applicable requirements are met
Support product post-launch changes (e.g., product evolution, corrective actions) to ensure on-going compliance.
Create and maintain objective evidence of compliance to applicable electrical regulatory requirements
Stay current with any changes to regulatory landscape i.e., new requirements, that may affect Magic Leap products.
Bachelor's Degree in Electrical or RF Engineering
3-5 years experience with medical electrical standards (eg. IEC 60601) required.
7+ years of experience with IEC 60950 and recent work with IEC 62368
7+ years of US and OUS in regulatory compliance testing and certifications.
Strong interpersonal, communication, analytical and complex problem-solving skills.
The ability to develop partnerships with cross-functional teams within the company.
Ability to work independently and has strong team building skills.
Ability to work in a fast paced environment and keep track of details.
Ability to manage multiple work streams in parallel.
Proficiency with MS and Google software applications.