Validation Engineer

Vastek, Inc.

$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or higher in engineering (industrial, mechanical, etc.) or closely related field required.
  • Strong expertise in Metal Alloy and Nickel-Plating processes.
  • Proficient in Probability and Statistics for testing sample size determination.
  • Experience managing expectations at the Vice President level in a high-stakes environment.
  • Skilled in Gage Repeatability, Reproducibility, and Reliability assessments.
  • Knowledgeable in Metrology and Surface Engineering.
  • Advanced problem-solving and systematic root cause analysis capabilities.

Responsibilities

  • Determine proper test methods for assessing Nickel-Plating Stability in Mixed Flow Gas.
  • Evaluate impact of Nickel-Plating on OmniPod functionality through Pulse Width measurements.
  • Assess precision and bias using Gage Repeatability and Reproducibility methods.
  • Conduct Root-Sum Squared Method analysis to establish appropriate specifications.
  • Lead cross-functional teams in identifying root causes of contamination issues.
  • Build representative worst-case challenge samples to assess potential defects in production.
  • Identify contamination sources in the OmniPod manufacturing process and implement improvements.

Benefits

  • Collaborative environment with cross-functional teamwork opportunities.
  • Exposure to high-level management and project ownership.
  • Engagement in cutting-edge research affecting health and safety.
  • Focus on long-term process improvement initiatives.
Full Job Description
Enter Job Description... • Shape Metal Alloy and Nickel-Plating expertise to determine that Mixed Flow Gas is the proper test method to use to determine the impact of Nickel-Plating Stability. • OmniPod Product Expertise to evaluate how the Nickel-Plating Stability impacted primary functionality of the OmniPod as measured by Pulse Width. • Probability and Statistics expertise to determine appropriate sample sizes for the testing. • "Soft-Skills" to manage and meet the expectations of Vice President level management with $12,600,000 worth of impacted product. • Gage Repeatability, Reproducibility and Reliability to assess the precision and bias of the proposed test method and the applicable gage. • Metrology and Surface Engineering as well as Engineering Drawing to perform a Root-Sum Squared Method stack up analysis to determine and appropriate specification. • Engineering Drawing, OmniPod Product Expertise, and Force Testing expertise to evaluate the possibility of a Commutator Cap Nipple Crush Condition (a potentially severe defect if present in an OmniPod. • Advanced Problem Solving and Systematic Root Cause Analysis to lead a cross functional team in the identification of potential root causes and the development of corrective actions to permanently resolve the contamination issue. • OmniPod Product expertise to build worst case challenge samples representative of the types of defects seen in normal production conditions. The Beneficiary then partnered with lnsulet Corporation's internal chemistry team to determine appropriate testing to determine if the contamination could cause a health impact to users of the Omni Pod. • OmniPod Manufacturing Process expertise to determine potential sources of contamination present in the process and drive long term improvement to the process. Required Qualification & Experience:At least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, engineering management, manufacturing engineering, or a closely related field.

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