Bachelor's/Master's Degree in relevant engineering field.
5+ years of experience with Bachelor's or 3+ years with Master's.
CSEP certification required.
Proven experience in New Product Development (NPD).
Expertise in developing electromechanical devices.
Strong knowledge of medical device standards, especially ISO 14971 and IEC 60601.
Experience with Product Development Lifecycle Management.
Responsibilities
Perform system analyses to identify optimization opportunities and risks.
Apply research to enhance system designs.
Coordinate engineering requirements across teams.
Review documentation for compliance with standards.
Lead systems engineering strategy development and execution.
Mentor junior engineers on best practices.
Analyze requirements and produce design specifications.
Implement new systems engineering tools and methodologies.
Serve as a technical authority for complex issues.
Lead process improvements using lean methods.
Benefits
Health and wellness programs.
Opportunities for professional development.
Flexible work arrangements.
Access to cutting-edge tools and technologies.
Collaborative work environment.
Full Job Description
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.
