Systems Engineer II

• Understand, evaluate, and communicate system performance, desired behavior, and usability in the context of clinical use.
• Investigate internally and externally reported issues to determine root cause and propose process or technical resolution.
• Contribute to Corrective and Preventative Action (CAPA) and field Issue Investigation processes.
• Evaluate functional and performance impact of proposed design changes related to enhancements, cost-down, and component end-of-life issues and others.
• Perform subsystem requirement impact assessments, changes, review, and reconciliation.
• Track and communication status of deliverables.
• Support to implement best practices for documenting and effectively communicating system design changes.
• Acquainted with regulated development processes and standards for risk management, usability, and safety to ensure systems design changes and documentation meet relevant safety and regulatory standards.

• Bachelor’s Degree with 4 years to less than 8 years of relevant experience, or advanced degree with 3+ years of relevant experience.

• Advanced knowledge of Systems Engineering principles and best practices
• Strong communication skills
• Experience developing complex electromechanical medical devices.
• Strong grasp of design controls and good documentation practices.
• Demonstrated ability to collaborate and contribute to a cross functional team.
• Experience in requirements management, risk management, and system architecture documentation.

Medtronic