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