Brandon Bartels Email & Phone Number

Fort Wayne, Indiana, United States

New Product Introduction (Medical Implants and Instrumentation).

Fort Wayne, Indiana, United States

Role: Quality engineer (QE) supporting the manufacture of orthopedic surgical equipment. Primary focus: New product introduction (NPI) for several unique product lines. Activities Include: DFM, Capability Studies, Gage Design, Gage R&R, Quality Inspection Criteria Development; PFMEA/Control Plan Development; Non-Conforming Product.

Fort Wayne, Indiana

Role: Quality engineer (QE) supporting the manufacture of orthopedic surgical equipment. Primary focus: New product introduction (NPI) for several unique product lines. Activities Include: DFM, Capability Studies, Gage Design, Gage R&R, Quality Inspection Criteria Development; PFMEA/Control Plan Development; Non-Conforming Product.

Scottsdale, AZ

• Upgraded documentation and led team through a successful upgrade to ISO 13485:2016.
• Led team through multiple audits (MDD 93/42/EEC, ISO 13485).
• Managed the quality management system to ensure regulatory compliance with various governing bodies (FDA, EU, UK, Canada, Taiwan, Brazil, etc).
• Initiated transition to MDR, held management reviews, conducted internal audits, risk-management activities (ISO 14971), post-market surveillance, complaint handling, QMS training (implementation of risk-based training.
• Created and/or updated procedures for documentation control/approvals (SharePoint), risk analysis, non-conformance logging (incoming, in-process, and final inspection), QMS software verification, clinical evaluation.
• Completed purchasing of all 3rd party OEM products (force plates, pressure sensitive treadmills, etc.).

Scottsdale, AZ

• Developed an add-on module for the Noraxon testing software (C++) allowing for simultaneous product calibration of 8 sensors during a phase of production (saves ~33.75 hours/year).
• Performed V&V activities of next generation Noraxon products (Matlab, SPSS).
• Investigated algorithms and advanced statistics for integration into Noraxon software.
• Designed experiments for specification optimization of EMG, IMU Motion Capture, and Pressure Insoles.
• Developed user manuals and educational content.
• Performed software release testing activities (class A software) as per IEC 62304:2016.

Scottsdale, Arizona

• DOE to optimize sensor/receiver communication. Results influenced a design change that led to an increased range of wireless communication by ~10 meters or 25% (SPSS, Matlab, Excel).

Human Mobility Lab (PI: Dr. Claire F. Honeycutt)

• StartReact (also referred to as startle-evoked-movement: SEM) can be used to differentiate expert from non-expert typists. This suggests SEM to be a behavioral indicator of motor learning. Could it then be utilized to.
• FURI Grant ($800 total) Spring 2016 and 2017
• Society for Neuroscience Poster Presentation
• MS Thesis - Biomedical Engineering: ASU

• Individuals with Parkinson’s Disease (PD) often times experience asymmetric gait, a shortened step-length, and a phenomenon referred to as freezing of gait. These symptoms increase their likelihood to fall and decrease.
• Final design of device measured stride length in real-time with greater than 90% accuracy.
• Awarded 2nd place at the Bioaccel Solutions Challenge and received $1000 for further development.
• , design controls, software development (Arduino, Matlab, Swift), CAD (Solidworks), circuit design,prototyping, verification/validation(V&V) testing, DHF.
• See publication in the provided links below.

Tempe, Arizona

Product testing (incoming and final inspection), inventory management, and shipment coordination of medical equipment for 3rd world countries.

Master Of Science (M.S.), Biomedical/Medical Engineering, Gpa: 4.0/4.0

Activities and Societies: Dr. Claire F. Honeycutt's Human Mobility Lab, Society for Neuroscience

Bachelor Of Science In Engineering (B.S.E.), Biomedical/Medical Engineering, Gpa: 4.0/4.0

Activities and Societies: Fulton Undergraduate Research Initiative (FURI) - Spring 2016 and Spring 2017; Dr. Claire F. Honeycutt's Human.