Principal Manufacturing Engineer

Capital, Monteris Medical Corporation, Minnetonka, MN. Req. at least a Bachelors degree in Biomedical Engineering, Manufacturing Engineering or related Engineering fld. & at least 5 yrs of prog.responsible,post bacc exp. as a manufacturing or quality engr. in medical device manufacturing/process development. In lieu of a Bachelors plus five years of exp., Masters degree in Biomedical Engineering, Manufacturing Engineering or related Engineering fld. & 3 yrs. of exp. as a manufacturing or quality engineer in medical device manufacturing/process dev.is acceptable. Any suitable combo of edu., training &/or exp. is acceptable. Must have 3 years of exp w/each of the following: Coordinating cross-functionally w/ Engineering, Quality, Operations, & fld. Service teams; Statistical analysis tools such as Minitab; FDA regulations surrounding the manufacture of medical devices, GMPs & process validations; Developing & improving manufacturing processes related to the build of electro-mechanical systems; Development & qualification of equipment used in production; Support of Quality System Audits by regulatory bodies; & Risk based decision making w/in Medical Device Industry. Green Belt Certified at the time of application. ISO 13485 Lead Auditor Certification req. Role is located in Minnetonka, MN & requires on-site presence to provide direct support to production. Perform other duties as directed or assigned. For confidential consideration, please submit resume via email: careers@monteris.com. No agencies or phone calls please.recblid br87ciub7qmd3pmwpgtzntsg84cwpa