Kemi Faniyi

Biomedical Engineer and Product Strategist

Building safer medical products through design rigor, validation, and human-centered systems thinking.

Focused on

Biomedical Engineer with 3+ years of experience in medical device product development, quality engineering, and human-centered design.

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40%

Lower user error through iterative product design.

15+

SOPs authored and validated for regulated manufacturing.

$50K

Corrective actions avoided through early risk detection.

Professional Profile

Proven track record of leading cross-functional projects, from concept to validation, for medical devices. Deeply knowledgeable in Design Control (21 CFR 820), risk management (ISO 14971), and root cause analysis.

Core Competencies

Product Strategy

User research, journey mapping, UX and UI thinking, VOC, and risk-driven design frameworks.

Technical Execution

CAD, Arduino prototyping, design control documentation, data storytelling, and problem-solving under regulated constraints.

Leadership

Cross-functional team leadership, stakeholder alignment, and agile implementation.

Accessibility and Standards

Accessibility (WCAG, Section 508), design inputs and requirements, validation, and IEC 60601 safety standards.

Experience

Professional experience in quality engineering, education, and product design.

Experience across medical device product development, quality engineering, and product design engineering.

Quality Engineer

Benchmark Electronics | Rochester, MN

Dec 2022 - May 2024

  • Authored and validated 15+ manufacturing SOPs for regulated medical devices under FDA and ISO 13485 requirements.
  • Introduced visual workflow and documentation improvements that cut procedural errors by 30% for manufacturing technicians.
  • Surfaced early quality risks through trend analysis, preventing three potential manufacturing deviations and avoiding $50K in corrective actions.
  • Partnered across engineering and manufacturing teams to keep development activities aligned with quality system requirements.

Lead Teacher, Geometry

KIPP St. Louis High School | St. Louis, MO

Jun 2020 - Jun 2022

  • Designed interactive learning systems using iterative user-feedback loops and behavior-centered design principles.
  • Built structured training frameworks later adapted for technical training and FDA compliance modules.
  • Applied data-driven instructional design methods that increased student engagement and participation by 90%.

Product Design Engineering Intern

UNandUP, LLC | St. Louis, MO

Jul 2019 - May 2020

  • Contributed to a functional testing system through CAD prototyping, user research, and hardware integration.
  • Built control logic for a testing prototype using Arduino and embedded sensors.
  • Performed ergonomic design iterations for a pump grip, reducing calibration variability by 15%.
  • Authored ISO-aligned SOPs that translated engineering specifications into repeatable technician workflows.

Design Systems Projects

Medical device development, validation, and process improvement projects.

Projects listed in the resume with links to supporting case studies and portfolio documents.

Process Improvement Case Study

Filyn AI

Concept tool for identifying regulatory submission risks during pre-submission review, blending remediation workflows with risk scoring.

  • Designed one-click remediation for unsigned FDA Form 1571 issues under 21 CFR 312.23.
  • Applied Minitab-powered risk scoring across critical gaps and team velocity indicators.
Open case study

Washington University in St. Louis

Medical Device Development and Validation

An FDA Class I imaging system developed from concept through validation with attention to usability, safety, and cost efficiency.

  • Architected a $1,200 imaging system against a roughly $250K commercial benchmark.
  • Ran usability testing and risk analysis aligned with FDA design control and IEC 60601 expectations.
Open case study

UNandUP

Fluid Delivery System Prototype

Prototype fluid delivery system integrating pumping, in-line heating, and documentation workflows for safe repeatable performance.

  • Developed the system around a peristaltic pump and in-line heating module.
  • Integrated hardware, software, usability, and manufacturing requirements into one prototype path.
Open case study

Education

Master of Arts in Teaching

Saint Louis University | 2022

BS Biomedical Engineering

Minor in Electrical Engineering | Washington University in St. Louis | 2020

BS Biology

Minors in Applied Mathematics and Sculpture | Jacksonville University | 2018

Leadership

President, National Society of Professional Engineers

Jacksonville University chapter, 2017 to 2018. Increased membership by 25% through targeted outreach and programming.

Director of Dual Degree Affairs

Washington University BME Advisory Board, 2018 to 2019.

Technical Toolkit

Tools, standards, and methods that support compliant product delivery.

Fusion 360SolidWorksArduinoMATLABMinitabFigmaISO 14971ISO 1348521 CFR 820IEC 60601IQ/OQ/PQCAPASPCRCAWCAG and Section 508

Start A Conversation

Open to product, quality, and medical device conversations.

Available for opportunities and collaborations in biomedical engineering, product development, quality systems, and medical device innovation. Especially interested in roles where cross-functional execution, human-centered design, and regulatory rigor shape better product outcomes.

Email: pfaniyi@gmail.com

Phone: (314) 652-3648

Location: St. Louis, MO

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