Systems Engineers

Job Title

Minimum Required Skills/Education:

• Bachelor's / Master's Degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent.
• Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as System Architecture, System Design, Hardware Engineering or equivalent.
• Engineering Professional (CSEP).
• Significant experience in New Product Development (NPD) and can speak to experience through the full product life cycle.
• Expertise developing electromechanical devices with hardware and software elements.
• Deep understanding of medical device standards such as ISO 14971 and the 60601 series.
• Product Development Lifecycle Management.
• Simulation Software.
• CI/CD

Job Responsibilities:

• Perform system analyses and modeling to identify optimization opportunities and risks.
• Apply research and industry trends to improve system designs.
• Coordinate systems engineering requirements across R&D, manufacturing, and regulatory teams.
• Review system documentation to ensure compliance with engineering standards and regulations.
• Lead development and execution of systems engineering strategies.
• Mentor junior systems engineers on methods and best practices.
• Analyze system requirements and produce detailed design specifications.
• Introduce and test new systems engineering tools and methodologies.
• Serve as a technical authority for complex systems engineering issues.
• Lead cross-functional process improvement initiatives using lean methods.
• Write product and element requirements with rationale.
• Decompose medical device standards (IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72).
• Lead deep-dive FMEAs.
• Evaluate requirement failures and translate findings into subsystem requirements.
• Ensure control measures flow into the Risk Management File and DHF.
• Translate system-level risks into software, electrical, and mechanical requirements.
• Develop V&V protocols and test plans.
• Build trace matrices across the V-model.
• Lead technical reviews to align cross-functional teams.