Validation Engineer - Equipment

Sunnyvale, CA 94089

Employment Type: Direct Category: Manufacturing Engineer Job Number: 8988

Job Description

As an Equipment Validation Engineer, you will contribute to improving healthcare through faster, more accurate diagnostic tests. You’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the world’s most complex health challenges.

 

Qualifications:

  • Bachelor of Science in Mechanical, Biomedical, Plastics or Industrial Engineering or equivalent
  • Experience in medical device manufacturing or biomedical assembly process development or other regulated industries
  • Quality Management System (QMS) experience, Statistical Process Control (SPC)
  • Strong familiarity with ISO 13485, GMP (Good Manufacturing Processes)
  • Demonstrated experience in a quality/validation engineering role with emphasis on equipment and process validation, qualification test protocol (IQ/OQ/PQ)
  • Familiarity with automated assembly or manufacturing equipment
  • Familiarity with hand tools, power tools, clean room environment
  • Strong communication and interpersonal skills
  • Ability to work on-site, travel 5%

 

Responsibilities:

  • Support equipment qualification and validation activities
  • Develop, plan, execute equipment/utility/facility qualification and validation protocols for manufacturing equipment, automation systems and processes
  • Develop process characterization plans and experiments to improve existing assembly processes
  • Validate new automation processes, equipment and/or designs in collaboration with a diverse functional engineering team
  • Analyze test data, prepare detailed reports, prepare and maintain validation and compliance documentation as required
  • Support continuous improvements in processes

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