Engineer II, Systems in Bangalore, भारत

Engineer II, Systems role at Baxter involves designing and developing medical device products from conception through verification and validation. The position requires applying systems engineering principles, managing requirements, and collaborating across cross-functional teams to deliver innovative healthcare solutions in a regulated environment.

Responsibilities

• Define and translate customer, business, regulatory, and safety requirements into system specifications and requirements
• Lead requirements engineering activities including use case development, traceability, and change management
• Execute risk management activities per ISO 14971 to ensure product safety and regulatory compliance
• Partner with cross-functional teams to resolve technical challenges and support product integration testing
• Develop technical documentation communicating system architecture, design decisions, and development outcomes

Requirements

• Bachelor's degree in Mechanical, Electrical, Electronics, Software, Computer Science, Biomedical, or Industrial Engineering
• 3-6 years of systems engineering experience with electro-mechanical product development focus
• Experience developing complex products in regulated industries, preferably medical devices
• Working knowledge of FDA regulations, Medical Device Regulation (MDR), and quality standards
• Experience with requirements management tools such as DOORS or Polarion
• Familiarity with usability engineering, human factors methodologies, and design tools like QFD and DFR
• Strong analytical skills, cross-functional collaboration ability, and excellent communication