Evan Fair

Role & Responsibilities:

• Managed product integration, compliance, and quality assurance to support the transition of acquired technologies into established product lines.
• Assisted in documenting and standardizing 7 product SKUs within company systems to ensure alignment with internal and external standards/requirements.
• Contributed to the launch of a new product SKU, supporting regulatory, manufacturing, and quality processes.

Key Achievements:

• Product Integration & Standardization – Facilitated the incorporation of seven SKUs into company records, ensuring consistency and traceability.
• New Product Introduction – Supported the market release of a new SKU, coordinating technical and compliance efforts.
• Manufacturing & Process Scale-Up – Helped expand production capacity and optimize shelf life, transitioning devices to higher-volume manufacturing.
• Quality & Compliance Leadership – Assisted in verification, validation, and risk management efforts to maintain product standards.
• Cross-Functional Collaboration – Worked with R&D, quality, and manufacturing teams to refine processes and improve efficiency.
• Mentorship & Leadership – Provided technical oversight and guidance to a university senior design team, supporting engineering education and real-world application.

• Published research in Nature: Scientific Reports, contributing to advancements in bio-printing and tissue engineering.
• Initiated and actively oversee the Research and Development of a Functional Heart, leveraging bio-printing and advanced biotechnologies.
• Developed methodologies to manufacture a fully operational heart capable of sustaining volumetric flow, optimizing functional performance.
• Focused on deriving and manufacturing heart components from living tissue (Mesenchymal stem cells) to improve biocompatibility and integration.
• Conducted experimental research, data analysis, and validation studies to advance biomedical engineering solutions in regenerative medicine.

Role & Responsibilities:

• Drove rapid innovation in the design and development of orthopedic medical devices, ensuring high-quality and impactful solutions.
• Worked across the entire product lifecycle, from concept generation to manufacturing, contributing to the company's technological advancements.
• Collaborated with surgeons and cross-functional teams to develop minimally invasive surgical (MIS) devices, optimizing performance and usability.
• Assisted in the development and refinement of the ArchiMIS Precision Delivery Device and DragonWing, enhancing bone delivery standards in surgical applications.

Key Experience:

• Product Design & Development – Led the design and refinement of orthopedic devices using SolidWorks, optimizing for manufacturability and clinical effectiveness while producing detailed 2D drawings with GD&T for vendor manufacturing.
• Manufacturing & Process Optimization – Designed injection-molded components to reduce tooling costs, improve production efficiency, and scale manufacturing from startup levels to broader distribution.
• Regulatory & Quality Compliance – Supported FDA design documentation, patents, FMEA risk analysis and quality assurance efforts, ensuring products met regulatory and safety standards.
• Verification, Validation & End-User Testing – Developed testing protocols, conducted design validation labs, and collaborated with end users to refine product functionality and usability.

• Cooperated and collaborated with various engineers on several projects: Robotic Automation to improve manufacturing output, Pneumatic Machine optimization using Inductive Proximity Sensors, Modeled and revised designs for several parts used in the manufacturing floor to improve efficiency, effectiveness or ergonomics
• Developed an Air System optimization program to control humidity, dew point, Sweating Slab Syndrome (SSS), perceived temperature, and wet- and dry-bulb temperatures
• Mathematically analyzed and designed a program to assist in the development and manufacturing of new parts formed from raw materials
• Industrial Demagnetization of the factory line products.

• Assisted in the installation, testing, and servicing of CT Scans, Sonar, and MRI machines, ensuring proper functionality and calibration.
• Operated CT Scan equipment during maintenance procedures, troubleshooting issues and performing basic system diagnostics.
• Gained hands-on experience with medical imaging technology, understanding system components, maintenance protocols, and performance optimization.
• Collaborated with senior technicians to evaluate equipment performance and support system upgrades in hospital and clinical settings.

• Shadowed the Operations Manager at Dräger HQ South Africa, gaining insight into operational workflows and supply chain management.
• Observed and participated in the sterilization and maintenance of medical equipment, ensuring compliance with health and safety regulations.
• Assisted in equipment inspections and process optimization, contributing to efficiency improvements in sterilization procedures.
• Gained exposure to quality control and facility operations, supporting efforts to maintain high industry standards in medical device servicing.