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Manufacturing Engineer Consultant
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- Manufacturing Engineer working as part of a team supporting the production of disposable medical devices, such as laser atherectomy catheters for peripheral and coronary procedures, support catheters, and lead removal tools.
- Our daily work that includes both sustaining and project work – we strive to complete the types of projects that remove the need for sustaining work – improving safety, quality, output and eliminating scrap.
- Daily sustaining work includes troubleshooting and developing solutions for various chemical and mechanical issues, especially with respect to the following: epoxies - mixing/ curing/ drying/ wicking/ polishing; plastic tubing - fusing/ flaring/ forming/ injection molding; fiber optics – drawing, coating, curing, winding, stuffing, polishing; equipment troubleshooting/repair – simple mechanical machines, temperature controllers, PLC’s, HMI’s, motion controllers, etc.
- packaging and sealing pouches and trays; cleaning – ultrasonic, ionizers; testing – burst, tensile, leak, optical gauge, FTIR, DSC, SEM; CAD modeling – Solidworks, and more!
- Process validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a and a clear understanding of FDA’s QSR and cGMP, and a good grounding in statistics would be instrumental to success.
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