Medical Device Development Engineer

Job Summary

Medical Device Development Engineer, seeking a full-time contract professional with experience in medical device product development, responsible for system-level design, requirements management, and compliance activities.

Key Responsibilities

• Lead system requirements analysis, documentation, and product design activities
• Own and maintain Design History File (DHF) documentation and traceability
• Coordinate with cross-functional teams to ensure compliance and support verification and validation activities

Required Qualifications

• Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field
• 3-10 years of experience in Medical Device product development
• Proficiency in MS Word and Excel
• Strong experience in requirement analysis, risk management, and DHF traceability
• Hands-on experience with IEC 62366 and ISO 14971 standards