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.

MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law.

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