Kevin Zheng

About Kevin Zheng

Med device engineering leader with experience in manufacturing, quality, R&D and technical leadership. Successfully commercialized and launched 10+ Class II & medical devices including implants, catheters, stents, electro-mechanical devices with software, and high-volume disposables. I love developing and launching innovative products to serve patients.I pride myself on being the \"go to person\" that my team and management can count on to deliver challenging projects and goals. I am a leader that enjoys developing and mentoring others to achieve their ambitions and potential. I strive to achieve business goals but will not compromise integrity. In my previous individual contributor roles I was a Manufacturing and Quality lead engineer. I was the product development team member for my functional area and worked with the cross-functional team (R&D, Quality, Manufacturing, Regulatory, Marketing, Finance) to bring multiple class medical devices through the full product development cycle (concept and feasibility to full commercial launch). My technical skills include:Technical program and project managementBudgeting and financial analysisStrategic planning, executing to short & long term goalsComplete product development cycle (concept & feasibility to commercialization, post launch support)Design Control (Design Requirements, Verification, Validation)Risk Management (FMEA, Quality Control Plan, CAPA)Regulatory SubmissionsInternal and External AuditInspection, Process & Equipment Validation (Test Method Validation, IQ, OQ, PQ)Production Scale-up & Production Site Transfers Process optimization (performance, cost, yield, quality, supply)Supplier qualification and scale upStatistical Techniques Certified Quality EngineerCertified Six Sigma Black Belt (Completed multiple projects and mentored others)My Soft Skills and Leadership Style:Trusting, coaching style of leadershipRoll up my sleeves and get into the details whenever I\'m neededEffective communicator to all levels of the organizationBuilding trust and collaboration, gaining buy-inWorking through difficult situationsStrategic thinkerConstant learnerHiring and developing the best organization / teamListening and being an inclusive leaderThinking big, setting ambitious goals and delivering results

Experience

1. Sr Director of Quality Engineering

   Intuitive

   Aug 2025 — Present · Sunnyvale, CA, US

Education

• UC Irvine

  BS, Biomedical Engineering

  2003 — 2007

• UC Irvine

  MBA

  2012 — 2015

Skills

• Minitab
• 21 Cfr Part 11
• Medical Devices
• Gage R
• Capa
• Fda
• Regulatory Submissions
• Iso 13485
• Lean Manufacturing
• Six Sigma
• Root Cause Analysis
• Statistics
• Quality System
• Quality Assurance
• Design for Manufacturing
• Cross-Functional Team Leadership
• Iso 14971
• Design Control
• Fmea
• Validation
• Design of Experiments
• Process Validation
• Equipment Installation