Work Flexibility: Hybrid
Role and Responsibilities:
Lead the design and development of mechanical components and systems for medical devices, executing end-to-end current product development (NPD) across all product lifecycle phases—from concept generation and detailed design through verification, validation, and product launch.
Own engineering change management activities, including impact assessments, documentation, approvals, and implementation, while coordinating with cross-functional stakeholders to ensure timely execution.
Translate user, clinical, and business needs into engineering requirements, product specifications, and system-level designs. Perform engineering analyses, including simulations, engineering calculations, tolerance analysis, and statistical evaluations, to optimize product performance, quality, and reliability.
Prepare and maintain comprehensive engineering documentation, including Design History Files (DHF), Device Master Records (DMR), engineering drawings, Bills of Materials (BOMs), labelling, Instructions for Use (IFUs), engineering specifications,



and design records, ensuring compliance with company standards, regulatory requirements, and quality system procedures.
Prepare and maintain detailed 3D models, engineering drawings, schematics, and specifications using CAD software, preferably Creo Parametric, while applying GD&T; in accordance with industry standards.
Collaborate with laboratory teams to plan and execute verification and validation (V&V;) activities, including test method development, protocol preparation, test execution, data analysis, and technical reporting.
Partner effectively with cross-functional teams including R&D;, Quality, Manufacturing, Regulatory Affairs, Clinical, Marketing, Supply Chain, and Operations to deliver projects within scope, quality, cost, and schedule.
Support prototype development, design verification, design validation, manufacturing transfer, product launches, value engineering, cost reduction initiativ

📌 Senior Design Engineer (Gurugram)
🏢 Stryker
📍 Gurugram