Position Overview
Rhaeos is a clinical-stage MedTech startup backed by The Steele Foundation for Hope. Rhaeos has created an innovative flow velocity sensor that has wide applicability across healthcare, with its first indication being for hydrocephalus. We are completing our final stages of our Pivotal Study in preparation for our commercial launch in 2025. We are hiring our Head of Software Engineering to drive future indications driven by software innovations.
We have partnered with Anna Lisa Somera, CEO, and Chad Webb, CTO, to hire our Head of Software Engineering. This position will work closely with the technical team to enhance utilization and expand use indications by creating additional data collection, analysis, and reporting functionality. This hands-on leadership position will be responsible for leading software development strategies while working with the technical team for the development of new features, applications, and remote patient monitoring products along with post-market product maintenance activities.
Position Details
Responsibilities
Leading internal and external software engineering teams:
• Collaborate with the engineering leadership team to define software resource needs.
• Guide external software partner strategy and own the relationships.
• Drive operational processes and task execution for both internal and external software teams.
• Manage software projects from concept to completion, including planning, resource allocation, risk management, and delivery.
• Guide, mentor, and develop software engineers, fostering a collaborative and high-performing team.
Delivering software solutions as part of a product ecosystem aligned to company strategy:
• Collaborate with the broader engineering, commercial, clinical and regulatory teams to design software systems that deliver outstanding solution experiences for customers.
• Partner with the hardware team to develop a fully integrated product ecosystem, ensuring seamless interaction between software and hardware components.
• Architect, design, lead and contribute to code for the development of user-facing mobile and web applications, ensuring robust and scalable solutions that meet product and business requirements.
• Drive innovation in software solutions, proactively identifying and addressing technical challenges, and contributing to the continuous improvement of product performance.
• Collaborate to develop and implement strategies around machine learning algorithm pipelines, implementations, and development structures.
Ensuring software product safety, cybersecurity, quality and regulatory compliance:
• Deliver technical documentation for FDA regulatory submissions.
• Ensure all software deliverables meet rigorous quality standards, including adherence to FDA regulations, ISO13485, IEC62304 and other relevant industry standards.
• Continuously evolve architectures and processes to ensure current and future compliance with FDA, customer and healthcare industry cybersecurity expectations.
• Lead post-market surveillance of software products, including failure investigations and root cause analysis, to drive continuous improvement in product quality and user satisfaction.
Supporting customer deployment and sales processes:
• Develop and execute processes for deploying software products to end-users, including healthcare provider organizations, individual consumers and manufacturing partners.
• Interface with healthcare IT organizations to support sales implementations.
• Recommend and implement features, testing and/or documentation to support commercial teams.
Education & Training
• Bachelor's Degree or greater in Computer Science, Computer Engineering, or a technical field with relevant additional software development experience.
• 10+ years of experience in software development, with at least 3 years in a leadership role within the medical device industry.
Skills & Experience
• Experience with Python, React, NodeJS, TypeScript and iOS and AWS implementations.
• Proven experience in designing and leading the development and deployment of Software as a Medical Device (SaMD), including technical leadership in FDA 510k submissions for Class II and/or Class III devices.
• Demonstrated experience leading teams under IEC62304 standards, including familiarity with FDA cybersecurity requirements and EMR integration processes.
• Strong background in managing both internal and external software development teams.
• Track record of developing commercial software products, particularly iOS mobile applications, AWS data processing pipelines, and web portals with customer deployment.
• Experience leading both early program and post-launch growth software teams.
• Significant experience with digital signal processing for bio-integrated sensors, Bluetooth, IoT services, and cloud platforms.
• In-depth knowledge of developing Software as a Medical Device (SaMD), including real-time data processing and remote patient monitoring systems.
• Expertise in integrating medical devices with hospital Electronic Health Records (EHR) systems, using HL7, FHIR, and other relevant standards.
• Proficiency in designing cloud-based architectures for IoT-connected medical devices, with hands-on experience in AWS or other cloud platforms.
• Strong understanding of FDA cybersecurity guidelines and secure data transmission protocols for medical devices.
• Familiarity with FDA, ISO 13485, ISO 14971, and IEC 62304 regulations, ensuring compliance throughout the development and deployment phases.
• Proven ability to lead cross-functional teams, including software, data science, and regulatory specialists, while managing external development partners.
• Experience in developing and scaling remote patient monitoring systems that support real-time data capture, alerts, and actionable insights for clinicians.
• Strong knowledge of healthcare data privacy regulations (HIPAA, GDPR) and the implementation of cybersecurity features.
• Strong communication skills for effectively interfacing with clinical, regulatory, and IT teams at hospitals to ensure smooth integration and data flow.
Other Requirements
Based in, or willing to relocate to Chicago, IL
Company Overview
Rhaeos is a clinical-stage, venture-backed medical device startup pioneering a suite of wireless, wearable, and non-invasive diagnostic sensors. As the Head of Software, you will be responsible for leading the architecture, development, and deployment of software solutions that interface with Rhaeos' innovative wearable devices. Your role will be instrumental in driving technical strategy, managing software teams, and collaborating with external partners to deliver a cohesive and high-
performing product ecosystem. This position is based in Chicago, IL, within a company led by a seasoned medical device team.
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