Senior Mechanical Engineer in Redmond, WA at Volt

Date Posted: 2/12/2020

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Redmond, WA
  • Duration:
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Senior Mechanical Engineer 

I have an open position for one of my clients in Redmond, WA who is seeking a Senior Mechanical Engineer- Advanced Product Development for a full-time, direct hire role.  
• 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
• Participate in Material Review Board to: 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 

Job Requirements 

• BSME with 3-5+ 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
• 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

Volt is an Equal Opportunity Employer