Manufacturing Engineer

Halma p.l.c; Redmond (WA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life Insurance

Disability insurance

401(k)

Flexible spending account

Health savings account

Paid holidays

Paid time off

Parental leave

Employee assistance program

Job summary

MicroSurgical Technology designs and manufactures high-precision surgical instruments for ophthalmic procedures. The Manufacturing Engineer role focuses on improving production processes, choosing materials, optimizing machine operations, and advancing automation to sustain daily line performance.

The position requires a B.S. in engineering and 3–5 years in medical device manufacturing, with hands-on experience in fixtures, failure analysis, and FDA-compliant change management.

Qualifications

• B.S. in Manufacturing, Mechanical, or Industrial Engineering or equivalent experience.
• 3-5 years in medical device or hardware manufacturing with production support.
• Experience designing tools and fixtures for assembly, test and production.
• Experience responding to real-time production issues and implementing corrective actions.
• Certified SolidWorks Associate or 3+ years equivalent experience.
• Proficiency with inspection tools and methods.
• FDA manufacturing environment design change knowledge.
• Gage R&R analysis for equipment qualifications.

Responsibilities

• Revise existing product designs for improvements or new lines.
• Design new and revise fixtures for assembly, test, and inspection.
• Troubleshoot and conduct root cause analyses.
• Develop IQ/OQ/PQ and maintenance protocols for equipment.
• Maintain production assembly and inspection procedures through product life cycle.
• Develop validation protocols for equipment and processes, including cleaning and sterilization.
• Lead production process quality improvement initiatives.
• Determine training and certification requirements for operators.
• Support product failure analysis for customer complaints and returns.

Skills

Tool design

Root cause analysis

Process optimization

Quality systems

Education

B.S. in Manufacturing/Mechanical/Industrial Engineering

Tools

SolidWorks

Micrometers

Calipers

Optical comparators

Job description

Instrumentation for better flow and pressure control

Instruments for eye surgery

We make great products that people love.

At MST we believe in this philosophy. MST's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. It is our relentless pursuit of addressing our customers’ needs that creates a profound customer preference. We strive to equip surgeons with the most innovative tools, enabling them to achieve the best possible outcomes for the patients. We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology. Expanding our offerings into excisional goniotomy, we now market micro-instruments used for adult and infantile glaucoma, which improve the health and livelihood of patients by providing a safe and effective surgical intervention.

Company: MST

Function: Operations

Job Type: Regular / Permanent

Role Type: Full time

Location: Redmond, Washington

Job Description

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!

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.

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.