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Sr. Manufacturing Engineer - New York, United States - MicroSurgical Technology
Description
Company OverviewMicroSurgical Technology (MST) is a highly profitable ophthalmic surgical solutions company headquartered in Redmond, Washington. MST is part of Halma PLC, a UK-based conglomerate with over $2.3B in annual sales.
Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures.
Every MST product meets the highest standards and is designed with extraordinary care and attention to all elements of the product, including packaging, look and feel, and ease of adoption into practice.
Our product portfolio includes 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.
Founded in 1976, MST's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world.
Senior Manufacturing Engineer
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
Requirements:
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 and 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 for this position is $120k-$145k per year which is the general base range for a successful candidate in the State of Washington.
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 account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits.
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.
Please note that only qualified candidates will be contacted for further consideration.No Recruiters or Agencies Please