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Required Skill Set(s)

• Proven communication skills and ability to lead within a multi-functional team environment
• A demonstrated capacity for solving problems through creative designs
• Knowledge and experience using DFMECA FMEA, DOE.
• Knowledge and experience with statistical analysis (Minitab, ANOVA)
• Knowledge of MDR regulations and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices);
• utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why's, Ishikawa (Fishbone).
• 2 years progressive mechanical design experience in a regulated medical industry (link removed)>