Trevor Hafer Email & Phone Number

Draper, Utah, United States

Draper, Utah, United States

• Apply Quality Engineering tools to ensure that Ortho Development products conform to specified requirements.
• Evaluate and disposition of nonconforming materials and processes (MRB/NCR)
• Investigate issues, planning, implementation and verifying effectiveness of Corrective Action (CAPA/SCAR)
• Evaluate, investigate and resolve Complaints (PIR/Feedback)
• Create and review inspection plans (Control Plans)
• Collect, trends and analyzes data from various sources to report on effectiveness of processes and controls

Greater Salt Lake City Area

• Design and develop new medical device software and hardware for orthopedic procedures. Design includes strategies, prototypes, function, user interface, risk management, verification and validation procedures, and.
• Lead cross-functional teams in release of new products. Managing designs, timelines, and collaboration of tasks.
• Invented of one of the first orthopedic applications for Hip Preservation procedures. Assisted in clinical study demonstrating the device provides reliable quantitative measurements with minimal impact on surgical.
• Have observed 100+ live cases of orthopedic procedures to understand user needs and requirements. Translate user needs into design inputs and specifications to incorporate into products.
• Assisted in reorganizing and restructuring quality system and documentation. Wrote documents used for product development to address deficiencies and CAPAs. Created DHF file structure and verification and validation.
• Co-lead regulatory analysis and Co-author submissions, receiving FDA clearance of three unique products.

Draper, Utah, United States

• Devised and built layout for decontamination room doubling the capacity and return on an additional 2000+ units yearly.
• Designed and performed verification testing for products in development, advancing release of new products.
• Created solutions to improve design, manufacturing, and assembly process to reduce defects and failures.
• Performed troubleshooting, assembly, and repairs on electrosurgical generators. Assisted in repairing 500+ devices.
• Generated and managed method for tracking devices and shipments for trials and repairs increasing turnaround by 30%.

590 Wakara Way, Salt Lake City, Utah 84106

• Performed data analysis to identify the effect of abnormal hip kinematics in patients with hip disorders using CT and Dual-Fluoroscopy. Created 150+ models to evaluate hip joint angles and gait cycles affecting normal.
• Devised collaboration tools and data management log, enabling simultaneous teamwork and maximizing efficiency.

Salt Lake City, Utah

• Devised and built layout for decontamination room doubling the capacity and return on an additional 2000+ units yearly.
• Designed and performed verification testing for products in development, advancing release of new products.
• Created solutions to improve design, manufacturing, and assembly process to reduce defects and failures.
• Performed troubleshooting, assembly, and repairs on electrosurgical generators. Assisted in repairing 500+ devices.
• Generated and managed method for tracking devices and shipments for trials and repairs increasing turnaround by 30%.
• Evaluate and explore solutions to defects or failures in current products and perform quality and final testing/repairs on units.

Master Of Science - Ms, Bioengineering And Biomedical Engineering

• Formally trained on clinical problem solving; evaluated clinical problems, innovated ideas, engineered solutions and prototypes.

Bachelor Of Science - Bs, Bioengineering And Biomedical Engineering

Activities and Societies: Phi Eta Sigma Honor Society• Full Tuition Merit Scholarship Recipient • Formally trained in medical device.