Sr. Manufacturing Engineer jobs in United States
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MicroSurgical Technology · 22 hours ago

Sr. Manufacturing Engineer

MicroSurgical Technology is a company founded in 1976 that specializes in creating surgical devices and instruments. The Senior Manufacturing Engineer will be responsible for designing and revising tools and fixtures, creating test protocols, and leading production process quality improvements.

Health CareMedical Device

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

Qualification

BSMESolidWorks CertificationMedical Device ManufacturingGage R & R AnalysisDesign of ExperimentsMicrosoft OfficeInspection ToolsLean ManufacturingGD&TQuality Analysis

Required

BSME with 5-7 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

Preferred

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

Benefits

Medical
Dental
Vision
Life
Disability insurance
401K retirement plan
Flexible spending and health savings account
Paid holidays
Paid time off
Parental leave
Employee assistance program
Other company benefits

Company

MicroSurgical Technology

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With over 20 years of expertise in simplifying complex cases, MST stands at the forefront of delivering high-quality, surgeon-designed innovative ophthalmic solutions.

Funding

Current Stage
Growth Stage
Total Funding
unknown
2012-12-19Acquired

Leadership Team

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Erik Bror Bonn
Chief Strategy Officer (CSO), Vice President of Sales North America
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Jacqueline Carie
Sr. Talent Acquisition Partner
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Company data provided by crunchbase