Job Description :
Location: Lakeforest IL



Job Title: Contract Development EngineerLocations: United States - Illinois - Lake ForestDifferentiated 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.Role DescriptionThis role has primary responsibility for confirmation that medical devices and combinationproducts meet their intended function. This includes development of data through engineeringstudies that informs new product development as well as test reports that support productsubmissions. The candidate will work within a team environment to solve problems and utilizebest engineering practices and techniques for root cause and statistical analysis. This work entailsdefining test methods, developing protocols, performing data analysis, and writing reports incompliance 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 specificationsQualificationsB.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 REQUIREMENTSPhysical requirements include walking, standing, and performing analysis including protocol andreport writing. Includes hands-on test method development.



David

E mail: david at Infobahnsw    .    com

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