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Sr. Process Development Engineer-Reagents

Company: Joule Staffing
Location: Boston
Posted on: September 25, 2022

Job Description:

Title: Sr. Process Development Engineer-Reagents Location: Boston MA Duration: Direct Hire Start: ASAP Schedule : Monday through Friday 8:00am to 4:30pm Experience - BS degree in a relevant Engineering discipline such as Biomedical, Chemical, Mechanical or equivalent required (MS degree in a relevant Engineering discipline Preferred but not required) - 3 yrs. exp. with reagent or chemical process equipment in the in-vitro diagnostics or pharmaceutical industry required - 3 yrs. exp. with medical device / IVD development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems required - Strong hands-on skills with the ability to make routine mechanical and electrical repairs. Must be comfortable using basic tools and lab equipment - Knowledge of modern product development and project engineering principles, methods and practices Responsibilities: - Will be working with supply chain groups, vendors as well as develop/make cartridges, blood pumps and test products - Must own all technical aspects of this pilot line and be responsible for any repairs, maintenance and routine operation. This can include basic mechanical and electrical repairs as well as software and peripheral installation and maintenance - Will be solely responsible for the operation of a pilot production line for prototyping in-vitro diagnostic devices. They must be familiar with basic scientific processes such as reagent handling, pipetting, volumetric and gravimetric analytical techniques at the nanoliter level - This role will be responsible for the development and documentation of processes and procedures to ensure consistent and documented prototype production - This role must ensure consistent communication with the companies manufacturing facilities to confirm consistency between pilot line and production line processes. This will include any necessary travel - Analyzes experimental data, develops technical conclusions, and evaluates potential applicability of recommendations

Keywords: Joule Staffing, Boston , Sr. Process Development Engineer-Reagents, Engineering , Boston, Massachusetts

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