Sr. Manufacturing Engineer

Help grow a safer, cleaner, healthier future for everyone, every day.

MicroSurgical Technology

Senior Manufacturing Engineer

Redmond, WA (Onsite)

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

Key Responsibilities:

• Design new and revise existing tools and fixtures for assembly, test, and inspection
• Create test protocols for qualifying new products and assemblies
• Develop and document IQ, OQ, PQ and maintenance protocols for new equipment and fixtures
• Develop and implement automation/semi-automation equipment and fixtures
• Participate in Material Review Board, evaluate and disposition discrepant material, conduct failure root cause analysis, develop rework and repair methods, identify and document corrective and preventative action
• 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
• Revise existing product designs for improvement or new line extensions
• Develop test equipment and methods for mechanical, electrical, hydraulic, and pneumatic devices and systems
• 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
• 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
• Workflow design, yield improvement, waste reduction, time and motion efficiency studies
• Create and maintain Product and Process FMECA through product life

Qualifications:

• BSME with 5+ years of experience in medical device manufacturing
• Certified SolidWorks Associate or 3+ years of equivalent experience
• Microsoft Office applications, Excel power user
• Proficiency with inspection tools and methods
• Solid understanding of design change requirements and processes in FDA regulated manufacturing environment
• Ability to perform Gage R & R Analysis for equipment qualifications
• Ability to use Design of Experiments methods to support process improvement

Desirable Skills & Experience:

• Experience with metal machining and fabrication and finishing methods and equipment
• Swiss watch or jewelry manufacturing industry with insights into small tools, equipment, techniques
• Experience with color anodizing, electropolishing, chemical etching, laser etching
• Clean room, aqueous cleaning, and sterilization qualification and monitoring
• Lean manufacturing process implementation or support
• Mechanical specification using GD&T
• Quality analysis using MiniTab

Salary range: $120-145k

The pay range listed in this posting reflects the general base range for a successful candidate in the State of Washington. The successful candidate's actual pay will be based on various factors such as skills, qualifications and experience.

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.

This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings