R&D Engineer

Key Responsibilities:

• Design and develop new medical devices or plastic components using CREO / SolidWorks.
  
• Prepare and review engineering drawings, 3D models, and BOMs as per design standards.
  
• Manage and implement Engineering Change Requests/Notices (ECR/ECO/ECN) for design updates.
  
• Collaborate with cross-functional teams (QA, Production, Tool Room, Regulatory, Purchase) for new product introduction (NPI).
  
• Support design verification and validation activities, including DFMEA, risk assessment, and testing documentation.
  
• Prepare design history files (DHF), technical documentation, and ensure compliance with CE/FDA design control requirements.
  
• Participate in prototype development, testing, and design reviews.
  
• Ensure all product designs meet quality, safety, and regulatory standards.
  
• Continuously improve design processes and support cost reduction/efficiency projects.
  

Required Skills & Competencies:

• Proficient in CREO or SolidWorks (mandatory).
  
• Sound understanding of product design, GD&T, DFM, DFA, and tolerance analysis.
  
• Experience in ECR/ECN processes.
  
• Knowledge of medical device design and relevant regulatory requirements (ISO 13485, CE, FDA) preferred.
  
• Strong problem-solving, analytical, and documentation skills.
  
• Good communication and teamwork abilities.