Shanna Helminen
Senior Product Development Engineer @ RapidPulse, Inc.
About
Product Engineer with 20 years experience designing and developing catheters, guidewires, and other interventional and diagnostic devices. Experienced in all aspects of the medical device industry from concept development through product release in accordance with GMP/GDP standards as well as FDA regulations and ISO13485. Proven abilities to lead teams, solve complex problems and deliver high quality products. Experience in management of cross functional teams to complete projects on schedule and within budget
United States
Fort Lauderdale
Medical Device
Medical Devices, ISO 13485, Validation, Minitab, Manufacturing, Product Development, Design of Experiments, Design Control, Manufacturing Engineering, SPC, FDA, Solidworks, Biomedical Engineering, FMEA, Design for Manufacturing, SolidWorks
Experience
Shanna Helminen's Contact Information
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