Sr. Compliance Engineer
Newark, DE- 4 days a week onsite
up to $130k year max plus 10% bonus
Immediate hire with growing company. Will be responsible for compliance efforts for company products with regard to safety and EMC requirements through all product design/development phases as well as sustaining maintenance of business. As a member of Project Core Team, you will be responsible for reporting status of compliance activities. During early program phases the Compliance Engineer will support: Marketing & Regulatory efforts to identify applicable regulatory compliance requirements and provide technical translation of requirements to R&D teams. Work with Marketing, Systems, and Engineering teams to implement requirements into product definitions. Create Compliance Program Plans. Will support: Oversee EMC, & environmental pre-compliance and compliance testing at Certified Test Labs. Oversee IEC 60601-1 compliance testing. Act as the company compliance liaison to Test Labs and Certified Agencies e.g. UL, CSA, TUV, BSI. Develop EMC & Safety Certification test plans, Verification Procedures and Reports. Define compliance re-testing needs based on design changes. Participate in internal failure investigation and design changes where they arise during Compliance testingRequirements:
- 6+ years of experience in compliance testing and international certifications.
- An in-depth understanding of radiated and conducted emissions and susceptibility of systems, able to troubleshoot and will be a key problem solver on projects ,and must demonstrate a strong commitment to production needs.
- Knowledge of EMC design concepts and design practices
- Experience working with electrical test equipment including spectrum analyzers, vector network analyzers and signal generators a plus
- Experience with wireless technologies including WiFi and RFID
- The ability to develop partnerships with cross-functional teams across company sites.
- Understands device product manufacturing and product development & lifecycle processes
- Understanding of medical device compliance and safety standards a plus.
- Proficient at using laboratory test equipment used in electrical & RF engineering work. This includes most of the following: Multi-meters, Oscilloscopes, Spectrum analyzers, Function generators, Logic Analyzers, environmental chambers
- Proficiency in revision control for design and documentation a must
- Proficiency in at least one software language a must - e.g. Python
- Familiar with government-regulated and/or certified engineering environments (FDA, FAA, DoD, ISO)
- Medical device experience preferred but open to someone coming from aerospace, biotech/pharma, military design.
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