Ajay Bp

About Ajay Bp

Senior Mechanical Engineer with 8.5 years of experience across Semiconductor, Medical Devices, Pharmaceutical/Biotech Equipment, and Automotive industries. Expertise in New Product Development (NPD), sustaining engineering, and value engineering (VAVE), with end-to-end ownership from concept design to prototype validation, production release, and field support. Strong background in delivering reliable, manufacturable, and cost-effective design solutions in global engineering environments.Core Skills• 3D CAD: SolidWorks, Creo, NX, Onshape; large assembly design and detailing• GD & T: ASME Y14.5, tolerance stack-up analysis• Product Development: Concept design, feasibility studies, DFMA, DFX principles• Prototype & Testing: Prototype build, validation, test plans, troubleshooting, design iteration• Engineering Analysis: dFMEA, root cause analysis, design optimization• Design Change Management: Led ECO/ECN projects in compliance with QMS design controls, including design planning, risk management, verification & validation (V&V), documentation, and change approvals• Manufacturing: Fabrication, machining, automation systems, fixtures, SPMs, material selection, surface treatments• Tools & Systems: Agile PLM, Windchill, SAP; ECO, ECN, ECR processes• Standards: ISO, DIN, ASTM, ISO 13485, SEMIStrengths:• Cross-functional collaboration with global teams (US/UK stakeholders)• Strong problem-solving and structured engineering approach• Cost reduction, VAVE, and lean manufacturing (5S, Kaizen)• Effective project management and multi-project handling

Experience

1. Senior Mechanical Engineer

   Beckman Coulter Diagnostics

   Aug 2024 — Present · Bengaluru, IN

   Oversee mechanical lifecycle management for diagnostic instruments and modules, ensuring robust, manufacturable, and compliant solutions for in-vitro diagnostic (IVD) devices while adhering to ISO 13485, FDA, and medical device regulatory standards. Drive end-to-end design changes, risk mitigation, prototyping, verification & validation, and manufacturing support, collaborating cross-functionally to ensure product reliability, regulatory readiness, and operational excellence.Key Contributions:Managed lifecycle design changes as Change Lead, maintaining Design History File (DHF) and coordinating Engineering Change Orders (ECOs) with cross-functional approvalsDeveloped and maintained 3D CAD models, assemblies, and manufacturing/engineering documentation using SolidWorks and other CAD platformsApplied DFM, DFA, DFX, GD & T, and tolerance stack-up analysis to optimize manufacturability, assembly efficiency, cost, and qualitySupported design transfer from R&D to manufacturing, collaborating with internal teams and suppliers to resolve production, assembly, and field issuesPartnered with systems, electrical, software, quality, regulatory, manufacturing, and supply chain teams in design reviews, feasibility studies, and risk assessmentsCommunicated technical status, risks, mitigation strategies, and design rationale effectively to stakeholders

Education

• Jawaharlal Nehru National College of Engineering

  Bachelor of Engineering - BE, Mechanical Engineering

  2013 — 2017