Contract position: Global medical device manufacturer has an immediate need in Round Lake IL for a Principal Engineer. This is a contract position expected to last 8 months, could be longer based on performance, possible temp to hire. Responsible for leading the efforts in the coordination and management of standards compliance activities for assigned programs. This includes working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products. Great Contractor Benefits! Apply Now! Will hire ASAP!Responsibilities for the Principal Engineer
Requirements for the Principal Engineer
- Partner with design 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 product certification, compliance and safety issues.
- Consult with program teams on product certification strategy and compliance issues where needed
- Will work under the direction of the Product Certification and Labs Engineering Manager to ensure compliance of company hardware solutions with standards requirements. Will also support efforts to comply with environmental regulations.
- Facilitate and coordinate input from multiple cross-functional partners including program management, R&D teams, manufacturing sites and service locations to: develop comprehensive product certification and compliance strategies, develop and maintain therapy area compliance roadmaps and dashboards, and ensure that solutions comply with product certification requirements in the intended use markets (domestic and international).
- BS or MS in electrical engineering with 10 or more years experience in the design and implementation of complex embedded software systems. 5 or more years of experience in compliance engineering on complex design projects utilizing formal standards testing methodologies.
- Knowledge of medical device requirements for European Union, Canadian, Australian, INMETRO and UL standards.
- Knowledge of EMC in Medical Equipment and excellent understanding of EMC test equipment and testing method in accordance with domestic and international standards
- Knowledge of EMC regulations and certification procedures applicable to Medical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.).
- Ability to perform diagnostics and correct EMC failures in conjunction with design engineers
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.