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