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 managing end-to-end product trace matrices, performing trade-off analyses, and ensuring system reliability for medical device software.

Location: Remote - US

Salary: $138,000 - $180,000

Company

A leading digital healthcare company combining wearable biosensors and cloud-based data analytics to provide clinically actionable cardiac health information.

What you will do

• Lead stakeholder discussions to define and document system and subsystem requirements.
• Maintain detailed system architecture documentation and models using SysML.
• Support post-market monitoring of algorithm performance and conduct field complaint investigations.
• Manage end-to-end product trace matrices and design input/output relationships.
• Review software specifications, test plans, and design reports for technical accuracy.
• Collaborate with cross-functional teams to ensure seamless system integration and regulatory compliance.

Requirements

• Must be based in the US
• Bachelor’s degree in Engineering or a related field.
• 8+ years of systems engineering experience, including at least 2 years in SaMD/SiMD development.
• Proficiency in Python, Java, C#, or C++.
• Understanding of statistics and algorithm performance metrics.
• Experience with risk management activities and regulatory standards like IEC 62304 or ISO 14971.

Nice to have

• Experience with Agile/Scrum methodologies.
• Proficiency in requirements management tools like Jama, Polarion, or DOORS.
• Knowledge of MBSE, SysML, or UML.
• ASEP/CSEP certification.
• Experience using Splunk for data analysis.

Culture & Benefits

• Commitment to an inclusive and diverse workforce.
• Opportunity to work on life-changing cardiac health solutions.
• Collaborative environment focused on innovation and patient care.
• Equal Opportunity Employer with support for reasonable accommodations.