Full Job Description
Device and packaging configuration assessments to determine the worst-case devices to be tested in packaging and sterilization studies. Device and packaging configuration assessments to identify opportunities to streamline end-level packaging configuration changes. Write, prepare, and execute packaging testing protocols to conduct seal characterization studies to determine the effects of revised sterilization process and suppliers. Analyze data and prepare subsequent reports Write, prepare, and execute packaging testing protocols to conduct packaging design verification and distribution testing. Analyze data and prepare subsequent reports Coordinate sample sealing with process engineers and operations management in ISO class 7 and 8 cleanrooms. Organize all training of test protocols, sample submission, and testing with internal and external labs. Ensure activities are compliant with FDA design controls, processes and regulations. Create and/or update packaging design history files (DHF) to include current test report references, updated risk assessment documentation, and other design and quality assessments Prepare and implement packaging bills of materials (BOM) changes, and manufacturing procedure changes as needed Plan and/or attend regularly scheduled meetings (in-person and virtual) to ensure project timelines are maintained and that milestones are achieved. Attending daily review meetings and stand-ups with other departments for the latest updates. Confirm all required company-assigned training is completed on-time. Required Qualification & Experience:This role requires candidate to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical engineering, electrical engineering, manufacturing engineering or a closely related field.
