Job Title: Manufacturing Engineer
Company: MicroSurgical Technology
Location: On-siteRedmond, WA
Department: Manufacturing Engineering
Reports To: Sr. Manufacturing Engineering Manager
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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