Contract position: Global leader in the healthcare/medical product manufacturing industry is looking a Engineer I-Compliance Engineer in Round Lake IL to support the Product Certification team in product compliance and certification activities for global market launches. Expected to last 12 months, could be longer based on performance. Great Contractor Benefits! Apply Now!
Responsibilities for the Compliance Engineer
Requirements for the Compliance Engineer
- Partner with and support compliance engineers to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve EMC and product safety issues
- Work under the direction of the Product Certification and Labs Engineering Manager and/or Compliance engineer to ensure compliance of hardware solutions with standards requirements.
- Support efforts to comply with environmental regulations.
- Keep abreast of changes to product standards and regulations affecting medical products
- Ensure that all compliance test equipment complies with the test requirements specified in compliance standards
- BS degree in Engineering and 2+ years related experience in Electrical or Systems engineering
- Safety and Compliance experience, Working knowledge of regulatory submission processes including FDA 510(k)
- Experience with EMC design tools, automated EMC testing tools, electronic test equipment (scopes, logic analyzers).
- IEC 60601-1 family of standards, including EMI/EMC requirements
- Familiarity with quality and regulatory requirements (UL, CE, FCC, NOM) preferred
- Paid Vacation
- Health Insurance, and more...