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Sr. Design Verification %26 Valid Engineer -Electrical (Mundelein,IL)

Company: Medline Industries, Inc.
Location: Mundelein
Posted on: June 15, 2022

Job Description:

The Sr. R&D Verification and Validation Engineer (Electrical Engineering) is responsible for evaluating new and existing electromechanical devices (Class I and II) and technologies. This position will lead and execute design verification activities, implement and validate new test methodology, support testing for premarket submissions including 510k projects and CE Technical files, and lead process improvement initiatives. The Sr. R&D Verification and Validation Engineer will mentor lower level engineers, lead small project teams, and ensure business and project needs are met. This position will work with management to validate methodology and ensure results are traceable, repeatable, and compliant with industry and federal regulations. Major Responsibilities:

  • Test and evaluate new and existing products for compliance with electrical consensus standards (ex IEC 60601).
  • Develop, author, and execute design verification and validation protocols. Issue reports for regulatory audits, submissions and requests.
  • Create accurate and thorough documentation that records all steps taken and all measurements used through the verification and validation lifecycle.
  • Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
  • Analyze test results and contribute to design and failure investigations. Determine the root cause of defects, safety risks, and performance problems. Use the data to provide a risk assessment, identify mitigating factors and check for adherence to regulatory standards.
  • Lead test method development activities including test fixture design, equipment acquisition, and hardware/software validation
  • Provide technical expertise by understanding device design and core technologies to inform test method development, data interpretation and evaluation of product performance to verify product requirements and design inputs.
  • Lead process improvement, regulatory investigations, and data trending activities within the laboratory. Research and recommend new equipment and perform necessary qualifications.
  • Analyze test results and contribute to design and failure investigations. Determine the root cause of defects, safety risks, and performance problems. Use the data to provide a risk assessment, identify mitigating factors and check for adherence to regulatory standards.
  • Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.
  • Mentor other level engineers, lead small project teams and ensure metrics/timelines are met. Provide guidance to other engineers on design controls and test lab practices and procedures. Minimum Requirements:
  • Bachelor%26rsquo;s Degree required in Engineering (Electrical preferred) or equivalent knowledge
  • Minimum 4 Years of design verification or validation testing experience in the medical device industry (preferred - electromechanical devices or systems engineering). COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Preferred Requirements:
  • Experience analyzing and reporting data in order to identify issues, trends, or exceptions.
  • Experience evaluating information to determine compliance with standards, laws, and regulations.
  • Experience with ISO 60601 or other electrical consensus standards
  • Knowledge of FDA/MDR requirements and experience interacting with regulatory bodies as part of premarket submissions for FDA 510ks or CE Technical files
  • Experience with design controls, risk assessment, and root cause analysis.
  • Experience with process improvement and project management.
  • Working knowledge of ISO 17025 requirements
  • Experience with Good Documentation Practices, Good Laboratory Practices , and familiarity with Data Integrity requirements
  • Experience with process improvement initiatives (Six Sigma certification a plus)
  • Proficient with Microsoft Office (Word, Excel, PowerPoint)

Keywords: Medline Industries, Inc., Arlington Heights , Sr. Design Verification %26 Valid Engineer -Electrical (Mundelein,IL), Other , Mundelein, Illinois

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