Senior Systems Engineer II (Medtech)

TL;DR

Senior Systems Engineer II (Medtech): Developing and supporting software services for during-wear arrhythmia detection and reporting with an accent on system architecture, regulatory compliance, and cross-functional integration. Focus on defining subsystem requirements, maintaining SysML models, and ensuring SaMD (Software as a Medical Device) standards.

Location: Remote (Must be based in the US)

Salary: $138,000 - $180,000

Company

hirify.global is a leading digital healthcare company that creates wearable biosensors and cloud-based data analytics to detect, predict, and prevent cardiac disease.

What you will do

• Lead stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals.
• Maintain detailed system architecture documentation and models using SysML.
• Support post-market monitoring of algorithm performance using Python scripting.
• Manage end-to-end product trace matrices to illustrate design input/output relationships.
• Ensure compliance with medical device standards such as IEC 62304 and ISO 14971.
• Collaborate with Data Science, ML, and Software Engineering teams to integrate complex software services.

Requirements

• Bachelor’s degree in Engineering or a related field.
• 8+ years of systems engineering experience.
• At least 2 years of experience developing software-based medical devices (SaMD/SiMD).
• Proficiency in one or more of the following: Python, Java, C#, or C/C++.
• Experience developing technical product requirements, system architecture, and trace matrices.
• Must be located in the United States.

Nice to have

• Experience with Scrum and Agile methodologies.
• Knowledge of INCOSE/EARS best practices or ASEP/CSEP certification.
• Proficiency with requirements management tools like Jama, Polarion, or DOORs.
• Experience using Splunk for data analysis and monitoring.
• Knowledge of MBSE, SysML, or UML.

Culture & Benefits

• Fully remote work arrangement within the US.
• Inclusive workforce environment that celebrates diverse backgrounds and perspectives.
• Opportunity to work on life-changing cardiac health solutions.
• Rapidly growing company providing numerous opportunities for career advancement.