References

KEVIN KIM

kevinkim-portfolio.com
kevinhoangkim@gmail.com | (603) 858-0389 | Winchester, MA

My greatest strengths lie in innovative mechanical design, fostering cross-disciplinary collaboration, and driving excellence in product development. I excel at integrating advanced engineering techniques with user-centered solutions, as showcased by my diverse experiences across industries. I am passionate about mentoring teams and optimizing processes to drive both technical innovation and team growth.

Professional Experience

System and Method for Biopsy Processing

• Developed automated system for an external client’s autologous cell therapy targeting chronic kidney disease, reducing process times by 40%.

• Enabled the system to scale up processing to up to 100,000 tissue samples annually, supporting large-scale manufacturing. 

• Released 200+ custom mechanical parts for manufacturing and implemented GD&T, tolerance analysis, and DfX principles to optimize part quality and fit across designs.

• Established and executed a comprehensive V&V testing protocol, validating sterility, tissue digestion, and system reliability to meet stringent compliance requirements.

• Oversaw process validation activities, including operational qualification (OQ) and performance qualification (PQ), preparing system readiness for clinical applications.

• Coordinated cross-functional team efforts, bridging biology, controls, systems and test engineering disciplines to align on system requirements and deliverables.

• Managed risk assessments and implemented corrective actions, reducing validation cycle times.

• Delivered fully validated prototype units to client facilities, maintaining a 100% uptime during early operational phases.

System and Method for Centralized Fluid Management & Culture Control (US20210340486A1)

• Designed and implemented a centralized fluid management and culture control system for bioreactors, optimizing conditions for tissue growth.

• Led enclosure design using cast urethane for thermal insulation, overseeing vendor communication and assembly processes.

• Developed disposable pump cassettes, optimizing designs for injection molding and scaling production to over 500 units.

• Directed system assembly and commissioning of 10 complex prototype units, managing V&V testing and certifying compliance with product specifications.

• Produced detailed technical drawings for manufacturing over 50 custom parts using diverse fabrication methods including machining, sheet metal, rapid prototyping and injection molding. 

• Supported patent filing by providing technical documentation and design insights to the legal team.