Rithvik V.

About Rithvik V.

Experienced Senior Manufacturing Engineer with a proven track record in the medical device industry, specializing in process optimization, quality control, and project management. I have successfully led capacity expansion projects within the Suture Growth Initiative, integrating cutting-edge machinery for sutures welding, barbing, and packaging at the North Haven manufacturing plant. Previously, I contributed to the development and qualification of Continuous Glucose Monitoring products and processes as a Manufacturing Systems Engineer at Dexcom. My expertise includes the development and execution of comprehensive project plans, ensuring alignment with business objectives and adherence to timelines and quality standards. I am skilled in commissioning and validating automated systems. My background includes a Master of Science in Mechanical Engineering and ongoing pursuit of a Master of Business Administration. I am passionate about continuous improvement and leveraging Lean methodologies to enhance operational efficiency.

Experience

1. Senior Quality Engineer

   Amgen India

   Jan 2025 — Present · Hyderabad, IN

   As part of the Combination Product Operations Quality (CPOQ) team, I provide quality oversight and technical support for physical test methods and combination product operations, while managing projects that enhance compliance and efficiency. Key responsibilities include:Method Lifecycle Management: Oversee development, validation, qualification, transfer, and obsolescence of physical test methods for mechanical requirements such as Cap Removal Force, Activation Force, Injection Time, Deliverable Volume, and Needle Extension.Quality Assurance Leadership: Act as QA contact for change controls, deviations, CAPAs, and CAPA Effectiveness Verification, ensuring compliance with global standards.Project Management: Lead and coordinate quality-related projects, managing timelines, resources, and stakeholder communication to achieve deliverables on schedule.Cross-functional Collaboration: Partner with Combination Product Operations, Physical Systems Engineering, and supplier quality teams to review technical documentation and maintain alignment on specifications.Continuous Improvement: Drive initiatives to optimise document review cycles, improve workflows, and enhance operational efficiency within CPOQ.Regulatory Readiness: Ensure inspection readiness and adherence to QMS architecture through proactive engagement and governance.

Education

• MLR Institute of Technology

  Bachelor’s Degree, Mechanical Engineering

  2012 — 2016

• Wichita State University

  Master of Science (M.S.), Mechanical Engineering

  2016 — 2018

• University of the Cumberlands

  Executive MBA, Strategic Management

• Indian School of Business

  Technology Entrepreneurship Programme, Business Administration and Management, General