Director, Systems Engineering (Medtech)

TL;DR

Director, Systems Engineering (Medtech): Overseeing systems engineering and test functions for connected cardiac monitoring technologies with an accent on regulatory compliance, architecture definition, and lifecycle management. Focus on leading multidisciplinary teams, driving engineering rigor in a regulated medical device environment, and ensuring product safety and scalability.

Location: Remote (US), with up to 25% domestic travel required to California.

Compensation: $182,000 - $237,000

Company

hirify.global is a leading digital healthcare company creating wearable biosensors and cloud-based analytics to detect and prevent cardiac disease.

What you will do

• Lead and mentor multidisciplinary Systems Engineering and Test teams throughout the product development lifecycle.
• Define functional strategy, resource planning, and operating models aligned with business roadmaps.
• Drive the adoption of improved engineering processes, tools, and best practices for requirements management and traceability.
• Partner cross-functionally with RA/QA, Product Management, and R&D to ensure design inputs meet regulatory and clinical needs.
• Communicate project status, risks, and budget requirements to executive leadership.
• Support regulatory audits, submissions, and technical discussions for global markets.

Requirements

• 15+ years of experience in regulated medical device development (Class II/III).
• 8+ years of people leadership managing multidisciplinary engineering teams.
• Deep expertise in systems engineering practices (requirements, architecture, risk management, V&V).
• Working knowledge of FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and IEC 60601.
• Must be based in the US and available for up to 25% domestic travel.
• BS in Systems, Electrical, or Biomedical Engineering.

Nice to have

• Experience with AI-enabled tools in FDA-regulated environments.
• Relevant certifications such as INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma.
• Prior experience in cardiology or diagnostic medical device commercialization.

Culture & Benefits

• Commitment to an inclusive and diverse workforce.
• Opportunity to impact global cardiac health outcomes.
• Collaborative, fast-paced environment focused on patient-first innovation.
• Equal Opportunity Employer with reasonable accommodation support.