Sr. Systems Engineer II - Platform Services

iRhythm Technologies, Inc.; United States; On-site; USD 127,000 - 165,000; Full time

Job summary

iRhythm Technologies, Inc. is hiring a Senior Systems Engineer II to develop and support software services for arrhythmia detection. In this remote role, you will collaborate with cross-functional teams and tackle software engineering challenges to meet clinical needs.

The ideal candidate has a Bachelor’s degree in Engineering, 8+ years of systems engineering experience, and proficiency in Python and Agile methodologies. Join our dynamic team to make a difference in healthcare technology.

Qualifications

• 8+ years of systems engineering experience, including software-based medical devices.
• Understanding of statistics and algorithm performance metrics.
• Experience developing technical product/software requirements.

Responsibilities

• Lead discussions to define and document system requirements.
• Maintain system architecture documentation.
• Conduct compliance gap assessments.

Skills

Python

Software development

Agile methodologies

SysML

Data analysis

Education

Bachelor’s degree in Engineering or related field

Tools

Jama

Polarion

DOORs

Job description

Senior Systems Engineer II – Platform Services

In the Research & Systems Engineering team, you will develop and support software services enabling during‑wear arrhythmia detection and reporting. You will collaborate with specialists in Data Science/Machine Learning, Software Engineering, Mobile Technologies, Product/UX, Product Security, and Clinical to tackle software engineering and data science challenges that address unmet clinical needs. You’ll work alongside a skilled team, deepen your understanding of integrated systems, and contribute throughout the software development lifecycle.

Key Responsibilities

• Lead stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals; perform trade‑off analyses and present recommendations to leadership for alignment.
• Maintain detailed system architecture documentation and models (e.g., SysML), ensuring accurate system representation.
• Support post‑market monitoring of algorithm performance, including scripting (Python), and contribute to risk management and field complaint investigations.
• Manage end‑to‑end product trace matrices, illustrating design input/output relationships.
• Review and provide technical input to design deliverables such as software specifications, design documents, test plans, and reports.
• Collaborate with cross‑functional teams to establish workflows and ensure seamless system integration.
• Conduct compliance gap assessments, assist with regulatory submissions, and stay current with relevant standards (IEC 62304, ISO 14971, cybersecurity frameworks).
• Support cybersecurity initiatives and integrate security best practices into system and subsystem designs.
• Contribute to design transfer and software deployment or launch activities.

Required Qualifications

• Bachelor’s degree in Engineering or related field.
• Combined 8+ years of systems engineering experience (with a Bachelor’s); at least 2 years of experience developing software‑based medical devices (SaMD/SiMD). Candidates with a Master’s or PhD may qualify with fewer years.
• Understanding of the basics of statistics, including calculation of algorithm performance metrics (e.g., sensitivity, specificity).
• Experience with software development using Python, Java, C#, or C/C++.
• Experience developing technical product/software requirements, system architecture, and trace matrices.
• Experience supporting risk management activities.

Preferred Qualifications

• Experience supporting projects employing Scrum and Agile methodologies.
• Familiarity with medical device regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601‑1).
• Proficiency with requirements management tools such as Jama, Polarion, or DOORs.
• Knowledge of INCOSE/EARS best practices and guidelines; ASEP/CSEP certification considered advantageous.
• Knowledge of SysML, UML, or Model‑Based Systems Engineering (MBSE).
• Experience using Splunk for data analysis and monitoring.

Location and Compensation

Remote – US.
Estimated pay range: $127,000.00 – $165,000.00.

Equal Opportunity Employer

iRhythm Technologies, Inc. is an Equal Opportunity Employer and encourages you to apply regardless of age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran or disability status. We will consider for employment all qualified applicants with arrest and conviction records in accordance with applicable laws.