Vacancy expired!
- You'll work as part of a cross-functional team as the Subject Matter Expert on all Systems Engineering-related matters from concept and architecture through development and commercialization including:
- Design input requirements and specifications
- FMEAs and Risk Management
- Driving alignment between subsystem plans and design input requirements
- Usability evaluation plans and testing to meet international standards
- System safety risks to comply with ISO 14971
- Verification and Validation design and execution
- Design for Reliability and achievement of platform reliability goals
- You'll work closely with your manager to drive and expand the functional excellence of the entire team through mentorship and training.
- Bachelor's degree in Engineering (Mechanical, Electrical/Electronics, Biomedical). Master's degree preferred.
- 5+ years' systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
- Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience preferred.
- Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11 is required.
- Knowledge of FDA QMS requirements, ISO-13485, European Medical Device Regulations and Canadian Medical Devices Regulations.
- Experience with hardware and software interfaces, as well as the hardware and software architecture, is required.
- Knowledge of PLC tools such as JAMA is required.
- Knowledge of Agile principles of hardware engineering is preferred.
Vacancy expired!