Harikumar S

Becton Dickinson (Advanced Access Devices)

• Project management in collaboration with cross-functional teams (R&D, Quality, Regulatory, Manufacturing, and Marketing) to drive design control activities and ensure on-time delivery of project milestones
• Leading remediation activities to address gaps in design history files and technical documentation
• Planning project timelines, tracking deliverables, coordinating reviews, and managing stakeholder communication and status reporting
• Identifying project risks and issues, supporting mitigation planning, and ensuring alignment with regulatory and quality requirements
• Preparing and maintaining STED files, procedure pack files, design and development plans, and labeling documentation
• Working in PLM Master Control, (Next Generation Change Control system) NGCC – PEGA.

Johnson & Johnson (Joints Division)

• Designing and drafting in NX-CAD. Incorporate knowledge of customer use and product design to predict product effectiveness/ anticipate potential failures.
• Worked with Windchill PLM for various medical device projects tracking the products and updating for any revisions introduced. It includes CN creation and various documents routing.
• Worked with the US clients understanding the specific surgeon’s requirements and assessed scope and requirements to assist with MTO Device design determinations. Wrote technical document in accordance with standard template requirements.
• Worked as part of a team performing standard engineering work requiring application of DFMEA, Risk Assessment Summary procedures and criteria. Analyze and solve routine design and engineering tasks.
• Medical device documentation that assists in the preparation and participation in technical reviews and responsible for organizing data preparing appropriate documentation for assigned projects.
• Organized brainstorming sessions with the think tank in finding optimized solutions for the problem statement given.
• Ideation on the solution with project tracking, Presentation and Documentation.
• Worked with the Industrial Design Team to assess the user friendliness of the final idea and included the aesthetic changes.
• NX-CAD Modelling and Assembly of the product, accurate to measurement to 3D print.

• Gained hands-on exposure to medical device development workflows within an extracorporeal laboratory, including design inputs, validation strategies, and safety considerations for high‑risk devices.
  • Worked as part of a multidisciplinary team conducting animal studies and device aging tests to evaluate performance, reliability, chemical characterization, and biocompatibility for critical-care medical devices.
  • Contributed to a lung ventilator development project by supporting verification testing, test protocol execution, data documentation, and discussions on design improvements and clinical requirements with engineering and clinical teams.
  • Observed live cardiac surgeries to understand real-world clinical use of medical devices and operating room workflows, engaging with senior cardiac surgeons on essential device technologies, user needs, and unmet clinical gaps.