Senior Engineer, Systems C&S

Overview

Senior Engineer for Systems C&S contributing to design and development of a product or solution from conception through design verification/validation, with compliance to applicable codes and standards.

What you'll do

• Identify and define customer needs, functions, performance, usability, and safety requirements.
• Execute compliance testing with target cost, quality, and schedule throughout the product lifecycle.
• Run risk management in accordance with EN ISO 14971 to support product safety and compliance.
• Manage requirements using tools such as DOORS and perform requirements decomposition into modules and compliance requirements.
• Lead system integration by proactively addressing integration issues during development tests.
• Ensure compliance with IEC 60601-1 and related standards to support product approvals from external safety test labs and notified bodies.
• Support verification/validation by helping develop verification scripts with strong test coverage.

What you'll need

• Bachelor’s degree in Mechanical, Electrical, Electronics, Software, Computer Science, Bio-Medical, Industrial Engineering, or related field.
• 3 to 8 years of experience in codes and standards, testing, and system engineering for electro-mechanical system design.
• Experience in medical device development, FDA regulations, and MDR.
• Exposure to usability engineering processes and practices.
• Understanding and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
• Knowledge of medical device safety requirements (IEC 60601-1 and related collateral) and applicable regulatory requirements.

Details

• Location: Bangalore, Karnataka.