Robert Guthrie

About Robert Guthrie

Accomplished, versatile Engineer with expertise in design, development, qualification and production of high-technology electromechanical systems and FDA-regulated medical devices. • Applied knowledge of statistical process control (SPC), Lean Manufacturing / Six Sigma, failure modes and effects analysis (FMEA), design for manufacturability (DFM), DOE analysis, root cause FA/FDA hazard & risk analysis, geometric dimensioning and tolerancing (GD & T), short and long term gage capability. • Productive and organized, ensuring on-target project management, meeting all deliverables of multiple initiatives. • Analytical and precise, creating and validating new manufacturing and quality processes. Expert research, data analysis, report writing, and presentation skills. • Well-versed in advanced technical procedures, documentation, and compliance with DoD MIL-STD-962, FDA Title 21 CFR 803, 806, 807, 820, & 892, ISO 9001, ISO 13485, SOR/98-282, IPC, UL, and CE regulations. • Collaborative, engaging communicator who consults with cross-functional teams, customers and suppliers throughout the product development lifecycle to create winning product offerings.

Experience

1. Project Engineer

   Medtronic Cranial And Spine Therapies

   Feb 2024 — Present · Lafayette, CO, US

   Responsible for high visibility weekly Field Corrective Action update reports summarizing status of product notice and returns from customers. Reports sent to Sales Team Reps, managers, and RVPs. Support executive team meetings.

Education

• California State University, Fullerton

  BA, Pre-med

  1974 — 1977

• Sam Houston State University

  Certificate, Agricultural Mechanics

• Saddleback College

  AA Degree, Biology, General