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Contract Development Engineer

Integrated Resources INC

Contract Development Engineer

Lake Forest, IL
Full Time
Paid
  • Responsibilities

    Job Description

    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?:

    • BA Science, Engineering