Title: Compliance Engineer, Sr.
Location: Delaware
Reporting to: Sr. Manager of Electrical Engineering
Industry: Medical Device
Summary:
Are you coming from Electrical background but do enjoy regulatory work? You cannot just work for any company/mission, for you to get a sense of fulfillment the organization you work for needs to contribute to advancing society? If you answered yes to both questions, this is the perfect opportunity for you!
Responsibilities:
- Identify applicable regulatory compliance requirements, and provide technical translation of requirements to R&D teams
- Oversee EMC, & environmental pre-compliance and compliance testing at Certified Test Labs
- Participate in internal failure investigation and design changes where they arise during Compliance testing
- Supports CAPA projects and VIP projects, Cost reduction projects, EOL projects, and Operations
Qualifications:
- Knowledge of EMC design concepts and design practices
- Understands device product manufacturing and product development & lifecycle processes
- Familiarity with IEC 60601-1 & -2 or IEC 61010
- Bachelor's Degree in Electrical, RF Engineering, or equivalent
- 4+ years of relevant work experience
