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Manufacturing Engineer II


Location: Menlo Park, California
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Manufacturing Engineer II
Menlo Park, CA
12+ month contract
 

at least 18 month contract, newly acquired company and the lease on the building will expire in 2023 and not sure what comes next, Like to see 1 or more within Med Device, working knowledge of standard manufacturing equipment, CAD or SolidWorks, inspection testing and measuring, must have education

Manufacturing Engineer 2

Business Title: Manufacturing Engineer 2
Business Unit: Sports Med/ENT Operations
Department: Operations (Menlo Park, CA)

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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