Manufacturing Engineer

Job Summary

Design and improve manufacturing production processes, including material selection, machine operations, automation and quality control, with a strong emphasis on supporting and optimizing day-to-day production line performance.

Key Responsibilities

• Revise existing product designs for improvement or new line extensions.
• Design new and revise existing tools and fixtures for assembly, test, and inspection
• Troubleshoot and conduct failure root cause analysis.
• Develop and document IQ, OQ, PQ and maintenance protocols for new equipment and fixtures.
• Develop and maintain production assembly, test, and inspection procedures through product life cycle.
• Develop verification and validation protocols for equipment and processes, including validation of cleaning, packaging, and sterilization.
• Participate in Material Review Board (MRB) to evaluate and disposition discrepant material, conduct failure root cause analysis, develop rework and repair methods, identify and document corrective and preventative action.
• Develop automated data collection and reporting methods.
• Lead production process quality improvement.
• Determine training and certification requirements for assemblers and technicians for production processes and equipmen.t
• Provide product failure analysis support for customer complaints and returns.
• Perform workflow design, yield improvement, waste reduction, time and motion efficiency studies.
• Create engineering design and process change orders with required documentation, technical justification/change effects analysis, and impact to operations.
• Create, document, and conduct training and certifications for fixture/equipment operation, and critical methods.
• Perform other duties as assigned.

Qualifications

• B.S. in Manufacturing, Mechanical, or Industrial Engineering or equivalent experience.
• 3-5 years of experience in medical device or hardware manufacturing, with direct support of production manufacturing environments.
• Experience designing tools and fixtures for assembly, test and production.
• Experience responding to real-time production issues (non-conformances, downtime, bottlenecks) and implementing corrective actions.
• Certified SolidWorks Associate or 3+ years of equivalent experience.
• Proficiency with inspection tools (micrometers, calipers, optical comparators) and methods.
• Experience troubleshooting mechanical devices and performing root cause analysis.
• Solid understanding of design change requirements and processes in FDA regulated manufacturing environment.
• Ability to perform Gage R & R Analysis for equipment qualifications.

Pay Range

$90K-$120K per year. Compensation is determined based on job-related knowledge, skills, experience, education, certifications, internal equity, and market conditions. This position may also be eligible for a discretionary annual bonus and/or other incentive compensation.

This position is eligible for a benefits package that includes medical, dental, vision, life, and disability insurance; 401(k) retirement plan; flexible spending and health savings accounts; paid holidays; paid time off; parental leave; employee assistance program; and other company benefits.

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