Sr. Systems Engineer II - Platform Services (Medical Devices)

Location: Remote - US

Salary: $138,000–$180,000 per year

Company

hirify.global creates digital healthcare solutions that combine wearable biosensors, cloud-based data analytics, and proprietary algorithms to support cardiac monitoring and clinical care.

What you will do

• Define and document system and subsystem requirements while balancing technical, regulatory, and business objectives.
• Maintain system architecture documentation and models, including SysML-based representations.
• Support post-market monitoring of algorithm performance, risk management, and field complaint investigations using Python scripting.
• Manage product traceability matrices and review software specifications, design documents, test plans, and reports.
• Collaborate with Data Science, Machine Learning, Software Engineering, Mobile, Product/UX, Security, and Clinical teams on system integration.
• Support compliance assessments, regulatory submissions, cybersecurity initiatives, design transfer, and software deployment or launch activities.

Requirements

• Bachelor’s degree in Engineering or a related field.
• 8+ years of systems engineering experience with a bachelor’s degree, including at least 2 years developing software-based medical devices such as SaMD or SiMD. Candidates with a master’s or PhD may qualify with fewer years of experience.
• Experience developing technical product or software requirements, system architecture, and traceability matrices.
• Experience supporting risk management activities and calculating algorithm performance metrics such as sensitivity and specificity.
• Software development experience with Python or another scripting language, Java, C#, or C/C++.
• Strong analytical, troubleshooting, presentation, and cross-functional collaboration skills.

Nice to have

• Experience with Scrum and Agile methodologies.
• Familiarity with FDA, ISO 13485, ISO 14971, IEC 62304, and IEC 60601-1.
• Experience with Jama, Polarion, DOORS, Splunk, SysML, UML, or Model-Based Systems Engineering.
• Knowledge of INCOSE/EARS practices; ASEP or CSEP certification is advantageous.

Culture & Benefits

• Work in a collaborative, cross-functional environment focused on improving patient care.
• Contribute to cardiac health products used to detect, predict, and prevent disease.
• Inclusive workplace welcoming diverse backgrounds, experiences, skills, and perspectives.
• Reasonable accommodations are available for qualified individuals with disabilities during the application process.