Systems Engineers
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 (phone number removed)-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.
