Validation Engineer Test Methods
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
For further inquiries regarding the following opportunity please contact one of our Talent Specialists Vignesh at or Sri at
Title: Validation Engineer - Test Methods
Duration: 6 Months
Location: San Diego CA
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Duration: 6 Months
Location: San Diego CA
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Description:
Meet the team:
Join a dynamic and collaborative multi-disciplined engineering team at Client. We support the organization by standing up pilot manufacturing lines for new product development. These manufacturing lines are intended to prototype evaluate and validate product designs. This role is crucial to develop the software systems which capture store and view the data which is produced from the manufacturing line.
Join a dynamic and collaborative multi-disciplined engineering team at Client. We support the organization by standing up pilot manufacturing lines for new product development. These manufacturing lines are intended to prototype evaluate and validate product designs. This role is crucial to develop the software systems which capture store and view the data which is produced from the manufacturing line.
Where you come in:
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
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.
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
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.
What makes you successful:
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
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
Required Skills
Test Method Validation (TMV) or Gauge R&R
Vision-based equipment for Dimensional Inspection
Medical Device Industry Exp
Test Method Validation (TMV) or Gauge R&R
Vision-based equipment for Dimensional Inspection
Medical Device Industry Exp
Preferred Skills
Mechanical Tensile or Compression Testing (Instron)
Statistical Data Experience JMP or Minitab
Process Development (DOE)
Mechanical Tensile or Compression Testing (Instron)
Statistical Data Experience JMP or Minitab
Process Development (DOE)
Education: BS in Mechanical Engineering or Bioengineering
Number of Interviews: 2 (1st interview will be over Zoom/Teams 2nd will be onsite)
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
