Systems Engineer

Your role:

• Responsible for the overall Systems Engineering deliverables and activities including translation of user and business requirements to product requirements, technical approach and system architecture development, harmonization of system design among the relevant products and projects of the segment(s), allocation of derived requirements to subsystems, and integration strategy and methods.
• Drives refinement and translation of user requirements (including but not limited to clinical, serviceability, reliability, and manufacturability), regulatory requirements, and system architecture and concepts into functional requirements. Manage requirements to be compliant with requirement management policies and ensure coverage, quality, and full implementation of requirements.
• Responsible for technical approach, system top level design, feasibility of potential technical solutions, and allocation of derived requirements (including functionality, interface specifications and design budgets) onto affected subsystems. Plans and executes system-level design reviews.
• Owns system-level defect analysis and remediation during System Integration, Verification and Validation phases. Support Product Risk Management, regulatory and standard fulfillment and country approval.
• Manage technical risk by conducting thorough risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and developing risk control measures.

You're the right fit if:

• You've acquired 2+ years successfully developing complex medical devices and a focus in systems engineering (hardware, software, consumables), with experience in Sleep Therapy/Ventilation products and accessories highly desired. Experience in test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
• Your skills include strong understanding of System Design process, including Model-Based (MBSE/V Model) Design approach-conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally validation, Medical Device/ FDA Quality System Regulations (ISO 13485/14971/10993/18562, 17510 2015, IEC 62366 etc.) and clearance processes.
• You have a Bachelor's Degree, required in Engineering preferably in Systems, Biomedical, Mechanical or similar discipline, Master's degree, preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You've demonstrated a relentless focus on Patient Safety and Quality as an organizational value and bring highly effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.