Research Development Design Engineer - Radiology

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