Nolan Swailes Email & Phone Number

Burnaby, British Columbia, Canada

- Maintained and updated quality management system to ensure compliance with ISO 13485 and FDA 21 CFR Part 820- Reviewed and updated design changes, requirement documents, product plans, and validation plans- Investigated root cause for non-conformances and corrective and preventive actions (CAPA)- Aided in writing regulatory submissions for Health Canada.

- Organized the design plans and specifications required for each aspect of the medical device design process, according to ISO 13485- Aided in the creation and implementation of product design documents- Assisted in the risk management process according to ISO 14971, for new and existing medical devices- Performed continuous review and improvement of.

- Aided in the development of medical device design documents such as product specifications and test plans- Performed verification and validation testing on 3D printed prototypes- Migrated documentation into new organizational system to ensure regulatory compliance- Assisted in quality audits from regulatory bodies such as Health Canada and the FDA

Calgary, Canada Area

- Managed motion capture data collection for osteoarthritis study, comparing movement between patients with intra-articular knee injuries and healthy controls- Programmed MATLAB code to import and analyze biomechanical data- Developed and performed statistical analysis methods such as principal component analysis (PCA) on subject data

Calgary, Canada Area

- Worked on developing an imaging technique (quantitative susceptibility mapping) for use in magnetic resonance (MR) imaging of the brain- Performed literature review to adapt current imaging techniques- Programmed and tested imaging processing methods using MATLAB- Constructed physical models for image validation

Switzerland

- Updated and documented combustor operation concept for a new mid-range gas turbine combustor upgrade- Prepared validation tool for monitoring and validation of test measurement data during commissioning of gas turbine upgrade- Investigated exhaust temperature distribution differences between different operation modes- Prepared, verified, and documented.

Calgary, Canada Area

- Designed, built, and tested a working prototype (phantom) to model heart and lung movement in a patient for the purpose of validating magnetic resonance (MR) imaging techniques- Sourced and tested different materials for MR compatibility and similarity to human tissues- Assisted with ongoing projects such as in vivo catheter tracking- Presented the.