Manufacturing Engineer II #JN -062021-64905

Menlo Park, California
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -062021-64905

Purpose Of Job:

  • Support manufacturing in ongoing production, tooling, and fixtures in order to meet production schedules while enhancing productivity and product quality.

 Major Duties And Responsibilities:

  • Maintain manufacturing equipment/tooling calibration and preventative maintenance in coordination with Quality Assurance.
  • Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc.
  • Support commercial, clinical, and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
  • Support process development and validations and generate written reports that meet requirements of Class III / PMA product.
  • Participate in facilities engineering, planning, and execution when appropriate.
  • Assist in the design and development of manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
  • Work with product development staff to ensure that products under development are optimally manufacturable and to resolve manufacturing issues.
  • Investigate non-conformances generated on the Production Line. Determine root cause and document in Product Lifecycle Management (PLM) system.
  • Maintain GMP systems, including pre-production quality assurance as well as post production GMP compliance in coordination with Document Control, R&D, and Quality Assurance functions.
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

 Education Requirements:

  • Bachelor of Science in Engineering or related field.

 Experience Requirements:

  • 1+ years of experience in the Medical Device Industry.
  • Participation in a Product Development project under design control including development, verification, validation and transfer phases.
  • Experience in a startup environment with multiple tasks, responsibilities and projects preferred.

 Other Qualifications:

  • Working knowledge of standard machine shop equipment is required.
  • Working knowledge of SolidWorks or similar CAD software is required.
  • Experience with inspection, test, and measurement equipment (Instron, etc.) required.
  • Working knowledge of basic statistical techniques required.

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