Alexander Kuzner

Led cross-functional teams to deliver projects valued up to $10M+ on schedule and within budget through executive status reporting, risk assessments, and stakeholder alignment. Traveled globally to manufacturing sites in 4 countries for root-cause analyses and delivered customer-driven product configuration generating $2M+ in new revenue.

Managed 4–6 concurrent product development, value improvement, and manufacturing transfer projects, owning schedule, budget, scope, and risk. Coordinated 20+ person teams to deliver $1M+ initiatives, including FDA/quality-compliant process optimization producing $1,000,000 in annual cost savings while maintaining ISO 13485 and FDA Design Controls.

Provided technical leadership for product design improvements, injection mold tooling, and design verification/validation under FDA Design Controls and IEC standards. Authored and maintained product design specifications and led compliance support for FDA, Notified Body (e.g., BSI), and independent audits across ISO 13485 and EU MDR, including 510(k) support.

Supported new product development of a patented Class II electromechanical dental device integrating fiber optics and a PIC processor, contributing to IEC-aligned verification and lifecycle testing and 510(k) submission requirements. Designed and optimized 4–7 production assembly fixtures to improve manufacturing throughput and product consistency.

Activities and societies: Senior capstone (8 months, team of 5) sponsored by Herman Miller: led end-of-arm tooling design and presented final design to Herman Miller engineering leadership.

Earned a Bachelor of Science in Engineering with a dual major in Mechanical and Biomedical Engineering and a minor in Mathematics. Completed an 8-month senior capstone delivering a full design package for an automation cell with a $250,000 design budget and a $15,000 prototyping budget, sponsored by Herman Miller.