Manufacturing Engineer

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 equipment.
• 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

Pay Range: $90K-$120K per year. Compensation is determined based on job-related knowledge, skills, experience, education, certifications, internal equity, and market conditions.

Benefits

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.

About the Role

Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology’s passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients’ lives. Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas and knives, all designed for the delicate and intricate procedures required in microsurgery. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work!