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Contract Development Engineer

Company: Integrated Resources Inc.
Location: Lake Forest
Posted on: May 28, 2023

Job Description:

Differentiated Drug Delivery (DDD) is a combination product design and development organization focused on improving patients' lives through customer-focused innovation and broad-based access to quality medicines and products.

  • This role has primary responsibility for confirmation that medical devices and combination products meet their intended function.
  • This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions.
  • The candidate will work within a team environment to solve problems and utilize
  • best engineering practices and techniques for root cause and statistical analysis.
  • This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures. Responsibilities
    • Partner with Systems engineers in defining product requirements such that they are verifiable
    • Development of test fixtures, test methods, and performance of Test Method Validation activities
    • Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
    • Ensure integrity and compliance of data according to Standard Operating Procedures
    • Develop Verification Plans including test strategy
    • Utilize technical writing and statistical data analysis skills to write protocols and reports
    • As necessary, conduct root cause analysis and derive recommendations based on analysis of data
    • Translate inspections and tests methods into component and product specifications Qualifications
      • B.S. in Engineering or science discipline and 2 to 5 years related experience.
      • Familiarity with ISO standard test methods and related test instrumentation preferred.
      • Excellent analytical and communication skills required.
      • Ability to work and solve problems in team environment.
      • Technical writing skills are required for protocol and report writing . Physical/Mental Requirements
        • Physical requirements include walking, standing, and performing analysis including protocol and report writing. Includes hands-on test method development. What is the minimum education experience required?: Additional Information All your information will be kept confidential according to EEO guidelines.

Keywords: Integrated Resources Inc., Lake Forest , Contract Development Engineer, Engineering , Lake Forest, California

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