The Principal Engineer – Quality will support Quality Assurance, R&D, Manufacturing Engineering, and Operations in the design and manufacture of disposable medical catheters, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EN ISO 13485:2016, EN ISO 14971:2012, and CGMP.
The Engineer will also assist with design controls, design transfer, and design change of cardiac electrophysiology catheters and will work with engineers from R&D and manufacturing engineering to plan, perform, and test the processes required to convert R&D prototypes and processes into pilot production at the facility.
While the position will require hands-on work, it is expected that the incumbent will always be embedded in a cross-functional, product-centric team. Will ensure that the contents of Design History Files, Device Master Records, and Device History Records are accurately developed, that the designs are properly verified, and that manufacturing processes are validated or verified as needed, in accordance with the Company requirements, regulatory requirements, and guidelines. The Principal Engineer – Quality may supervise junior engineers or technicians.
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