Facilitate stakeholder discussions to define and document system and subsystem requirementsas well as workflows, balancing technical, regulatory, and businessobjectives
Oversee the end-to-end data flow from the medical device, through mobile connectivity (e.g., BLE,Cellular,Wi-Fi), and into the cloud infrastructure
Maintain and update system architecture documents and models to accurately reflect current designs
Contribute to the management of trace matrices linking design inputs to outputs at both system and enterprise levels
Review and provide input ondesign deliverables like -software specifications, design documentation, and V&V strategies, including test protocols and reportsas well as regulatory submissions
Participate in risk management throughout product development and during field complaint investigations
Assistwith design transfer and software deployment activities
Remainup-to-datewith industry standards and regulatory requirements
Bachelor’sin Engineeringor related fieldrequired
Combined5+ years of experience in systems engineering(with a Bachelors),ideallyin a regulatedindustry(e.g.medical device, automotive, aerospace, etc.). NOTE:Candidates with aMaster’sor PhD may qualify with fewer years of relevant experience
Experience definingrequirements anddata flows for mobile applications (iOS/Android) connected to IoT hardware
Experience withstandardscompliance and risk management
Technicalfluency to effectively translate concepts and collaborate with softwareand firmwaredevelopers
Strong communicationand cross-functional leadership skills to align business, technical, and regulatory stakeholders
Experience with software based medical devices (SaMD orSiMD) and familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1)
Familiarity withone or more IoT protocols -MQTT, CoAP, HTTP(S)
Proficiencyin the use of requirements management tools, such as Jama,Polarion, or DOORs
Knowledge of INCOSE/EARSbest practices and guidelines
Knowledge ofSysML, UML, or other modeling techniques