Research Development Design Engineer

Job Title: R&D Design Engineer – Radiology & Imaging Systems Department: R&D Design – Radiology Division Location: Vapi, Gujarat Reports To: Manager / Senior Manager – R&D Design Job Purpose: To drive product design, innovation, and continuous improvement for radiology and imaging systems such as X-Ray, C-Arm, Digital Radiography (DR), CT systems, and related accessories , ensuring superior quality, safety, and performance aligned with global standards. Key Responsibilities: 1. Product Design & Development Design and develop new radiology and imaging system components and assemblies including X-Ray, C-Arm, DR, and CT systems. Work on mechanical, electrical, and electronic system design — ensuring functional reliability, ergonomics, and manufacturability. Develop detailed CAD models, circuit schematics, and design documentation as per internal and regulatory requirements. Collaborate with cross-functional teams to convert design concepts into production-ready solutions. 2. Product Improvement & Quality Enhancement Analyse field and production feedback to drive design improvements for enhanced product quality, stability, and serviceability. Implement value engineering and cost optimization initiatives without compromising quality or compliance. Conduct root cause analysis for product failures and develop corrective design actions. Support internal validation and verification of new designs in coordination with Quality and Testing teams. 3. Prototyping & Testing Participate in prototype fabrication, assembly, and functional testing of newly developed or modified products. Coordinate with testing teams for performance validation, safety compliance (AERB / BIS / IEC 60601), and regulatory testing. Document and review test results to ensure design integrity and compliance with design inputs. 4. Documentation & Compliance Prepare and maintain design history files, BOMs, engineering change notes (ECNs), and technical specifications. Ensure all design activities comply with ISO 13485, IEC 60601, and BIS regulatory standards. Participate in internal design reviews and audits to maintain traceability and documentation control. 5. Collaboration & Support Work closely with Production, Quality, and Service teams to resolve technical challenges and support manufacturability. Provide engineering support during product installation, field trials, and customer demonstrations. Support the Regulatory & Documentation teams in preparing technical dossiers and product files for certification. Qualifications and Experience: B.E. / B.Tech / Diploma in Electronics, Electrical, or Mechanical Engineering. Minimum 5 years of experience in design and development of X-Ray, C-Arm, DR, or CT imaging systems and their accessories. Proficiency in CAD tools (SolidWorks, AutoCAD, Creo, or equivalent). Strong understanding of radiology equipment design principles , electrical circuits, and mechanical systems. Familiarity with ISO 13485, IEC 60601, BIS standards , and AERB compliance requirements. Skills and Competencies: Fluent in English (spoken and written) with strong technical documentation ability. Strong analytical, problem-solving, and innovative design capabilities. Excellent collaboration and communication skills for cross-functional teamwork. Good understanding of electro-mechanical integration and system-level product design. Hands-on experience in DFMEA, DVP, and validation documentation. Proficiency in MS Office and project documentation tools. Key Performance Indicators (KPIs): On-time delivery of design projects and product improvements Reduction in design-related NCRs and field complaints Successful validation and approval of new designs Cost and performance optimization achievements Design documentation accuracy and audit compliance