Biomedical Engineer - Software Systems

Job Summary

Supporting the full life cycle development of software applications, the full-time Biomedical Engineer - Software Systems will manage software projects, ensuring compliance with quality management systems and regulatory requirements while collaborating across teams.

Key responsibilities

• Support the Software Development Life Cycle (SDLC) of software projects/programs
• Establish design inputs and system-level software requirements, ensuring compliance with quality management systems
• Create and maintain software product Design History Files (DHF) and coordinate activities with regulatory and quality teams

Required qualifications

• Bachelor's degree in Biomedical Engineering or a related field
• 2 years of relevant work experience in software development for medical devices
• Knowledge of FDA and ISO guidelines for medical grade software development
• Experience with project management and cross-functional team collaboration
• Familiarity with software agile (SDLC) processes