Engineering Manager - Design Reliability
Basic Qualifications:
Master’s degree in Mechanical, Industrial, Chemical, Biomolecular Engineering or related field and three (3) years of experience as a reliability engineer or test engineer. Must possess three (3) years of experience with each of the following: Test engineering in medical device industry; Component complaint and product failure investigations to include pre and post market quality root cause analysis, CAPA and RPI; FDA CFR 21 part 820 requirements and ISO 13485, ISO 9001 and ISO 14971; Statistical tools and software to include DOE, ANOVA, Confidence and Tolerance Limits, Gage R&R and Capability analysis; Utilize Lean Sigma concepts for problem solving and root cause analysis; Reporting tools like Business Objects and data analysis tools like Excel and JMP; Computer and software packages to include MS Project, and Minitab.
