Research Development Design Engineer

Job Title:R&D Design Engineer – Radiology & Imaging SystemsDepartment:R&D Design – Radiology DivisionLocation:Vapi, GujaratReports To:Manager / Senior Manager – R&D DesignJob 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