17 days old

Quality Engineer - Mechanical

American Society of Civil Engineers
Mountain View, CA

Job Responsibilities:

  • Provide quality assurance leadership and support for mechanical product development, design change efforts, and manufacturing through participation on project teams. Perform the following types of tasks as needed, ensuring compliance with industry standards and regulatory requirements:
  • Support design verification and validation efforts through review of plans, review of design verification and validation protocols and reports
  • Support component and process verification and validation, design and technical reviews
  • Participate in risk management activities and assist in the management and maintenance of risk management documentation, such as process and design FMECAs, FTAs, risk analyses, etc.
  •         Participate in design for manufacturability analyses, reviews, and design transfer activities
  •         Support manufacturing cost reductions, yield improvements, and MRB failure analysis activities including process changes, tooling, and equipment.
  • Provide quality oversight of suppliers by auditing suppliers, working with Development and Materials on supplier selection, evaluating supplier changes, communicating with suppliers on development of and qualification of new components/processes, and addressing performance issues as needed to ensure successful business relationships.
  • Participate as a member of the engineering change board, ensuring that released parts and documents are accurate and complete; and ensuring that supporting documentation is adequate.
  • Collect and analyze Quality Management System data as assigned and present results to management.




  • BS degree in a recognized engineering discipline, preferably Mechanical Engineering
  • 5 years minimum experience as a quality professional, preferably in a medical device or related industry
  • Familiarity with FDA Quality System Regulations and ISO 13485:2003/2016 highly desirable.  Familiarity with ISO 9001:2015, QS-9000, and knowledge of ISO safety standards is a plus.
  • Experience in product manufacturing & development, project management, and supplier auditing/management highly desired
  • Experience in statistical analysis, sterility/biocompatibility, packaging/transit testing, accelerated aging, laser welding, and/or guidance/standard compliance preferred
  • Excellent interpersonal skills, both written and verbal, are essential.  


Additional Salary Information: We provide a comprehensive compensation program including salary, benefits and pre-IPO stock options


  • Construction / Skilled Trades
  • Engineering
  • Financial Services
  • Manufacturing / Production
  • Healthcare

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Quality Engineer - Mechanical

American Society of Civil Engineers
Mountain View, CA

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Quality Engineer - Mechanical

American Society of Civil Engineers
Mountain View, CA

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