Senior Systems Engineer (Medtech)

TL;DR

Senior Systems Engineer (Medtech): Developing and enhancing mobile applications for cardiac health monitoring services with an accent on end-to-end data flow from medical devices to cloud infrastructure. Focus on defining system requirements, managing risk, and ensuring regulatory compliance for SaMD and non-medical device applications.

Location: Remote - US

Salary: $115,000 - $149,000

Company

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

What you will do

• Facilitate stakeholder discussions to define and document system and subsystem requirements and workflows.
• Oversee end-to-end data flow from medical devices through mobile connectivity to cloud infrastructure.
• Maintain and update system architecture documents and models.
• Manage trace matrices linking design inputs to outputs at system and enterprise levels.
• Review design deliverables including software specifications, V&V strategies, and regulatory submissions.
• Participate in risk management and field complaint investigations.

Requirements

• Must be based in the US
• Bachelor’s degree in Engineering or a related field.
• 5+ years of experience in systems engineering, ideally in a regulated industry.
• Experience defining requirements and data flows for mobile applications connected to IoT hardware.
• Experience with standards compliance and risk management.
• Technical fluency to collaborate effectively with software and firmware developers.

Nice to have

• Experience with software-based medical devices (SaMD or SiMD).
• Familiarity with medical device regulations (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1).
• Proficiency in requirements management tools like Jama, Polarion, or DOORs.
• Knowledge of SysML, UML, or other modeling techniques.

Culture & Benefits

• Opportunity to work on life-changing cardiac health solutions.
• Inclusive workforce that celebrates diverse backgrounds and perspectives.
• Commitment to professional growth and career development.
• Equal Opportunity Employer with a focus on patient-first innovation.