Kyle Flakne

About Kyle Flakne

Since childhood, I’ve been driven by a singular goal: to innovate and build solutions that improve lives. As a Mechanical Engineer with over a decade of cross-functional experience in medical device design, I specialize in developing cutting-edge products that align with regulatory standards while addressing real-world needs. My passion lies in creating intuitive, user-centered designs that are not only functional but also seamlessly manufacturable and inspectable.Currently, I lead a multidisciplinary team at Johnson & Johnson MedTech, contributing to groundbreaking projects such as the OTTAVA™ Robotic Surgical Platform and INTUITION™ Instruments for the ATTUNE™ Knee System. From concept to commercialization, I focus on integrating mechanical, electrical, and software systems, driving innovative solutions for complex surgical challenges.With expertise in CAD modeling, tolerance stack-up analysis, advanced GD & T, and a variety of manufacturing methods—including CNC, 3D printing, and injection molding—I excel in transforming ideas into tangible, impactful products. My work is fueled by a deep appreciation for the human body and a commitment to the upstream factors that influence long-term health and downstream development of technologies that support its repair and maintenance.Whether leading teams, mentoring colleagues, or collaborating with surgeons and stakeholders, I thrive on solving complex problems and delivering results that enhance patient outcomes and advance healthcare innovation.Common Misspellings: Kyle Flanke, Kyle Flankey, Kyle Flakney

Experience

1. Staff Design Engineer, Digital Surgery Engineer V

   Johnson & Johnson MedTech

   Oct 2022 — Present · Cincinnati, OH, US

   Lead Design Engineer - October 2022 to Present)• Led a multidisciplinary team of design engineers, designers, and test engineers to develop robotic accessories for the Ottava™ Robotic Surgical System.• Solved complex technical challenges through innovative designs, enhancing system performance and ensuring patient safety.• Partnered with regulatory and quality teams to ensure compliance across multiple quality systems and operating companies.• Conducted detailed tolerance stack-up analysis to ensure system functionality across components and subsystems.• Acted as primary engineering point of contact for program leadership, translating complex technical issues into actionable insights. & (Project Engineer - March 2025 to Present)• Took on business-facing responsibilities for R&D scope execution, including budget management and resource planning.• Generated detailed work breakdown structures and guided the R&D team to stay focused and aligned on critical deliverables.• Balanced technical priorities with strategic business objectives, supporting alignment across cross-functional teams.• Presented recommendations to project core teams, enabling informed decision-making and effective program direction.

Education

• Marquette University

  Bachelor of Science (B.S.), Mechanical Engineering

  2007 — 2012

Skills

• Product Design
• Process Verification
• Design Control
• 3d Printing
• Metal Injection Molding
• Ansys
• User Experience Design
• Inspection
• Python
• User Interface Design
• 3d Modeling
• Process Validation
• Validation
• Failure Mode and Effects Analysis (Fmea)
• User Interface
• Product R&D
• Computer-Aided Design (Cad)
• User-Centered Design
• Product Innovation
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Design for Manufacturing
• Iso 13485
• Solidworks
• Microsoft Office
• Gd&T
• Nx Unigraphics
• Finite Element Analysis
• Tolerance Analysis
• Injection Molding
• Problem Solving
• Geometric Dimensioning
• Risk Management
• Fmea
• Mechanical Engineering
• Human Factors
• Autocad
• Unigraphics
• Research and Development (R&D)
• Engineering