Fiona Madden Email & Phone Number

Canada

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

• Key contributor to cutting-edge new product development of tumor localization technology for oncological breast surgery to improve patient outcomes and surgical precision, in a fast-paced start-up environment.
• Owned V&V activities to support regulatory submissions by developing and executing test protocols for benchtop verification testing, User Validation, and Usability.
• Presented design iterations to key stakeholders to receive feedback during the design and development phase of new product development.
• Participated in design transfer activities by working with a contract manufacturer to ensure an accurate DMR was generated.
• Participated in hazard analysis generation for new medical devices following ISO 14971 requirements.
• Conducted CAPA and NCR investigations and root cause analysis to identify product issues and determine design improvements to increase product quality.

Hamilton, Ontario, Canada

• Analyzed gait patterns of patients after surgical removal of proximal femur sarcoma cancer - using 3D kinematic analysis to simulate impacts of surgery - to determine the best surgical technique to preserve patient.
• Determined which muscles and muscle attachment locations of the proximal femur have the greatest impact on patients’ gait biomechanics, while developing a framework using computational biomechanics to bridge the gap.

Hamilton, Ontario, Canada

Burnaby, British Columbia, Canada

Focused on new product development in the Endoscopy Division by designing 3D models using SolidWorks, prototyping, and testing new surgical visualization products under strict deadlines for clinical trials.

Mississauga, Ontario, Canada

• Designed 3D models of prototypes using SolidWorks to prove viability of solutions; presented proposed solutions to engineering teams, created engineering drawings, worked with fabricators to create prototypes for proof.
• Collaborated in cross-functional teams to design mechanical components while considering engineering, serviceability, and cost constraints.

Burlington, Ontario, Canada

• Developed new shear for manufacturing process by analyzing the existing system, identifying its problems, and creating SolidWorks models to increase the number of steel sheets cut per hour.
• Communicated with external electrical and mechanical engineering firms for parts fabrications, ensuring each component passed technical standards under strict time constraints.

Burlington, Ontario, Canada

• Developed multiple manufacturing components and implemented them into the production line while monitoring their performance to validate the improved processing capabilities.
• Gained experience with Lean Six Sigma methodology through participation in daily productivity huddles and Kaizen events.

Master Of Applied Sciences, Biomedical Engineering

Bachelor Of Engineering - Be, Mechanical Engineering, 4.0 Gpa

Graduated with Distinction

Education record

Ontario Scholar