Manufacturing Engineer II #JN -062021-64905
Menlo Park, California
Posted on: June 2, 2021
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.
- Bachelor of Science in Engineering or related field.
- 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.
- 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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