Anshul Sharma

About Anshul Sharma

Detail and result oriented engineer with 9 years of experience with responsibilities…

Experience

1. R & d Product Owner - Systems Engineering - Embolics

   Siemens Healthineers

   Mar 2024 — Present · Austin, TX, US

   We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.• Led the design transfer of Class IIb and Class implants from another company to Varian under Federal Trade Commission oversight, directing and owning engineering efforts through product V&V, labeling, and user documentation to meet global regulatory requirements. • Successfully launched the product in over 40 countries, driving revenue 4x since initial launch.• Within the 1st month of joining, identified and pitched a solution projected to save approximately 30% of the DV cost for a single maintenance release using Statistical Techniques based on historical data.• Author and SME for the Global Statistical Guidance on Design Verification document.• As the risk management lead, I led risk file updates for a new EU indication application, identifying and mapping new side effects from clinical literature to existing harms, and creating new harm entries as needed. Collaborated closely with clinical teams to support the risk-benefit analysis (RBA), ensuring alignment with EU regulatory expectations and contributing to a strong submission package.• Leading the transition to electronic Instructions for Use (eIFUs) by collaborating with the software team and providing HTML-based mockups for interface design. Working closely with the medical team to identify critical content that must remain in paper form, while also owning packaging design changes to support the regulatory and usability requirements of this digital shift.• Implemented automated MES data mining using scripts written in Python to guide cost reduction activities.• Rapid mastery of frequently used tools: PyCharm, Minitab, SAP, InDesign, Illustrator, Solidworks, JIRA, etc.

Education

• Stanford University School of Medicine

  Professional Program, Medical Statistics

  2021 — 2022

• Michigan Technological University

  Master of Science - MS, Mechanical Engineering

  2015 — 2017

• UPES

  Bachelor of Technology - BTech, Automotive Design Engineering

  2011 — 2015

Skills

• Composites
• Engineering
• Quality
• Lean Manufacturing
• Social Networking
• Design of Experiments
• Manufacturing
• Supply Chain Management
• Microsoft Excel
• Powerpoint
• Optimization
• Lean Process Improvement
• Employee Relations
• Microsoft Word
• Siemens Nx 8
• Hypermesh
• Lean Thinking
• Public Speaking
• Mechanical Engineering
• Microsoft Powerpoint
• Teamwork
• Team Management
• Project Management
• Solidworks
• Microsoft Office
• English
• Computer-Aided Design (Cad)
• Finite Element Analysis
• Ansys
• Catia
• Structural Analysis
• Cad