Test Method Validation Engineer
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions. Please apply or call one of us to learn more For further inquiries about this opportunity, please contact one of our Talent Specialists, Hema at (630) 847-0275 (or) Vignesh Chinnaiyan at (224) 507-1296 Title: Test Method Validation Engineer Duration: 6 Months with potential to extend and convertion to FTE Location: San Diego, CA Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered. Shift Time - 8 AM to 5 PM Overtime Hours: Possible 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. Where you come in: Develop test methods through Measurement System Analysis (MSA) and/or Gage Repeatability and Reproducibility (GRandR) 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 RandD, 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 Required Skills (top 3 non-negotiables): Test Method Validation (TMV) or Gauge RandR Vision-based equipment for Dimensional Inspection Medical Device Industry Exp Preferred Skills (nice to have) Mechanical Tensile or Compression Testing (Instron) Statistical Data Experience JMP or Minitab Process Development (DOE) Software Skills Required: JMP or Minitab is preferred, but not required Education Requirements: BS in Mechanical Engineering or Bioengineering Number of Interviews : 2 rounds 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.
