Engineer II, Sustaining - Wayne, NJ

Company: Getinge
Location: Wayne
Posted on: May 16, 2022

Job Description:

Job Overview

The primary responsibility for the Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting 510K testing for submissions, CAPA execution, writing and executing Test Method Validations, and working with component suppliers. This position will report to the Sustaining Engineering Supervisor.

Job Duties

• Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data.
• Write and execute Test Method Validations. Compile, analyze and report testing data.
• Update Design Specifications, Risk Management Plans and Reports
• Investigate and plan CAPA activities
• Communicate and Coordinate activities with other Getinge sites and outside component suppliers.
• Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, equipment registrations and other documentation).
• Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
  Minimum Requirements
  
  • Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical or Manufacturing Engineering with 2-4 years of related experience.
  • General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
  • Experience with process and equipment validations/qualifications.
    Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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