Sr. Systems Engineer I

About this Role: 

As a Senior Systems Engineer I within the Research & Systems Engineering team, you will play a key role in the development and enhancement of Mobile Applications supporting the Zio service. This position requires close collaboration with Firmware engineers, Software Engineers, and cross-functional partners including Product/UX/Labeling, Human Factors, and Product Security, to facilitate the launch of both SaMD and non-medical device mobile applications. This role provides an opportunity to engage with an experienced team, obtain comprehensive insight into integrated systems, and make significant contributions to the successful delivery of software projects in both US and international markets. 

Responsibilities: 

• Facilitate stakeholder discussions to define and document system and subsystem requirements as well as workflows, balancing technical, regulatory, and business objectives. 

• 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 on design deliverables like - software specifications, design documentation, and V&V strategies, including test protocols and reports as well as regulatory submissions. 

• Participate in risk management throughout product development and during field complaint investigations. 

• Assist with design transfer and software deployment activities. 

• Remain up-to-date with industry standards and regulatory requirements. 

About You: 

Required Qualifications: 

• Bachelor’s in Engineering or related field required;  

• Combined 5+ years of experience in systems engineering (with a Bachelors), ideally in a regulated industry (e.g. medical device, automotive, aerospace, etc.).  NOTE: Candidates with a Master’s or PhD may qualify with fewer years of relevant experience.  

• Experience defining requirements and data flows for mobile applications (iOS/Android) connected to IoT hardware. 

• Experience with standards compliance and risk management. 

• Technical fluency to effectively translate concepts and collaborate with software and firmware developers. 

• Strong communication and cross-functional leadership skills to align business, technical, and regulatory stakeholders. 

Preferred Qualifications: 

• Experience with software based medical devices (SaMD or SiMD) and familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1) 

• Familiarity with one or more IoT protocols - MQTT, CoAP, HTTP(S) 

• Proficiency in the use of requirements management tools, such as Jama, Polarion, or DOORs 

• Knowledge of INCOSE/EARS best practices and guidelines 

• Knowledge of SysML, UML, or other modeling techniques.