About this Role:

As a Senior SystemsEngineerIwithinthe 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 withFirmware engineers, Software Engineers, and cross-functional partners including Product/UX/Labeling,Human Factors,and Product Security, tofacilitatethe launch of both SaMD and non-medical device mobile applications.Thisroleprovidesan opportunity to engage with an experienced team, obtain comprehensive insight into integrated systems, and make significant contributions to the successful delivery of software projectsin both US and international markets.

Responsibilities:

• 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.

About You:

RequiredQualifications:

• 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.

PreferredQualifications:

• 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.