26 Aug
|
Vrinda International
|
Bengaluru
26 Aug
Vrinda International
Bengaluru
HIRING | Codes & Standards Engineer
We are hiring an experienced Codes & Standards Engineer for a medical devices organization in Bangalore.
• Experience: 7+ Years
• Location: Bangalore
• Work Mode: Work From Office – 5 Days a Week
• Budget: Up to ₹13 LPA
Mandatory Skills & Experience
• Robust hands-on experience with IEC 60601-1 and collateral standards
• Medical device standards and regulatory compliance
• Experience working with Notified Bodies and safety testing labs
• Experience with UL, TÜV, ETL, DQS, LNE or similar organizations
• Strong understanding of EU MDR requirements and CE Marking
• Experience preparing and maintaining Technical Files
• Experience with STED and GSPR documentation
• Experience supporting product certification and safety testing
• Experience handling audits and compliance activities
• Strong analytical and problem-solving skills
• Excellent communication and attention to detail
Key Responsibilities
• Ensure medical device products comply with applicable codes and standards
• Support certification, safety testing and regulatory compliance activities
• Coordinate with Notified Bodies and external safety testing laboratories
• Prepare and maintain Technical Files, STED and GSPR documentation
• Support EU MDR and CE Marking requirements
• Participate in audits and resolve compliance-related observations
• Work closely with cross-functional teams to ensure product compliance
📌 Codes & Standards Engineer (Bengaluru)
🏢 Vrinda International
📍 Bengaluru