DivIHN Integration Inc · 16 hours ago
Test Validation Engineer
San Diego, CA
Contract
Onsite
Mid Level
$60/hr - $66/hrDivIHN Integration Inc is a company focused on supporting organizations with pilot manufacturing lines for new product development. The Test Validation Engineer will develop test methods, lead validation activities, and collaborate cross-functionally to ensure test methods meet product and business requirements.
ConsultingInformation TechnologySoftware
No H1B
Hiring Manager
Hema Malini
Responsibilities
Develop test methods through Measurement System Analysis (MSA) and/or Gage Repeatability and Reproducibility (GR&R) methodology to assess and improve measurement reliability
Lead Test Method Validation (TMV) activities including protocol development, execution, and reporting
Create and release test fixtures or equipment including CAD, drawings, prototyping, fabrication and implementation into a manufacturing environment
Plan and perform Design of Experiment (DOE) to characterize and determine optimal processing and/or test methods
Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system
Analyze data using statistical tools (JMP or Minitab) to evaluate method/process performance and identify areas for improvement
Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to ensure test methods meet product and business requirements
Author and maintain validation documentation including protocols, reports, and risk assessments
Qualification
Required
Test Method Validation (TMV) or Gauge R&R
Vision-based equipment for Dimensional Inspection
Medical Device Industry Exp
Develop test methods through Measurement System Analysis (MSA) and/or Gage Repeatability and Reproducibility (GR&R) methodology to assess and improve measurement reliability
Lead Test Method Validation (TMV) activities including protocol development, execution, and reporting
Create and release test fixtures or equipment including CAD, drawings, prototyping, fabrication and implementation into a manufacturing environment
Plan and perform Design of Experiment (DOE) to characterize and determine optimal processing and/or test methods
Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system
Analyze data using statistical tools (JMP or Minitab) to evaluate method/process performance and identify areas for improvement
Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to ensure test methods meet product and business requirements
Author and maintain validation documentation including protocols, reports, and risk assessments
Strong problem solving skills when validating both destructive and non-destructive test methods
Highly familiar with vision-based metrology equipment
Have a preventative mindset through anticipating potential problems
Excellent written and oral communication skills
Flexibility to occasionally work 2nd shift based on equipment availability
Proficiency in statistical analysis software (e.g. JMP, Minitab)
Experience with project management tools such as JIRA, Confluence, Smartsheet
BS in Mechanical Engineering or Bioengineering
Preferred
Mechanical Tensile or Compression Testing (Instron)
Statistical Data Experience – JMP or Minitab
Process Development (DOE)
JMP or Minitab is preferred, but not required
Company
DivIHN Integration Inc
DivIHN (‘Divine’) has served as a holistic Technology Consulting entity since 2002, committed to Client Success & Transformation.
Founded in 2002
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Herald Ignatius Manjooran
Founder and CEO
J
John Sinkus
Senior Advisor
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