System Engineer

The Systems Engineering team drives the systems elements of R&D development projects including systems requirement definition and management, architectural definition, control/software/interface product specification and simulation, build integration, system testing and qualification to meet product level requirements.

To succeed in this role, you should have the following skills and experience:

• MS or PhD in relevant field including Systems Engineering, Electrical, Mechanical Engineering, or other related science.
• A minimum of 8+ years of experience successfully developing complex medical device (hardware, software, consumables) products for acute care/hospital markets is necessary.
• Additional technical knowledge and hands on experience in ventilation will be added advantage.
• Defines User Requirements, system requirements, FMEA, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration
• Experience with Sustenance Engineering, Change review Board, Defect Management
• Knowledge of medical regulations and standards.
• Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutions
• Analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
• Strong understanding of System Design process including Model-based Design approach and Test-Driven design methodologies
• Review System Verification and Validation plan/protocols, Test Method Validation (TMV)
• Conducting Technical Review & Decision Making
• Understanding of global medical device regulatory environments and clearance processes.
• Effective communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.
• Maintains strict confidentiality of sensitive information.