Senior Software Requirements Engineer IRC289491

Description

As a Software Requirements Engineer, you will get an opportunity to join a mature and senior team that is developing software for high-tech medical devices. The scope of our technical domain involves a comprehensive range of key functions for the medical industry with features such a robotic surgery system and 3D visualization. Our organization is considered as technical excellence, so we are paying special attention to the technical challenge and motivation of our team members

Requirements

Skills, experience & qualifications required:

• Education: B.S. or M.S. in Biomedical Engineering, Computer Science, or Robotics.
• Standards Mastery: 3+ years in a regulated environment with deep knowledge of ISO 14971 (Risk), ISO 13485 (QMS), IEC 62304 (Software Life Cycle)
• Tooling: Expert-level proficiency in Requirements Management tools like Jama.
• Technical Background: Familiarity with C++, Python, or ROS 2 to understand the technical limitations of proposed requirements.

• Offshore Experience: Proven ability to work asynchronously and communicate complex technical concepts in fluent English.

   

Job responsibilities

Key Responsibilities:

• Requirements Deconstruction: Translate high-level surgeon needs and clinical workflows into detailed, testable software requirements.
• Traceability Management: Maintain the Traceability Matrix linking user needs to system requirements, software requirements, software design, and verification evidence.
• Risk Analysis: Lead and/or collaborate with SQA to conduct Software FMEA sessions to identify software hazards and define risk control requirements.
• Cross-Functional Sync: Collaborate via remote tools with onsite hardware and systems engineers to resolve architectural trade-offs.