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 regulated medical device development and lifecycle management. Focus on establishing disciplined engineering practices, ensuring regulatory compliance, and leading multidisciplinary teams through NPI and sustaining phases.

Location: Remote (US); available for up to 25% domestic travel, primarily to San Francisco Bay Area or Southern California.

Salary: $182,000 - $237,000

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, develop, and mentor multidisciplinary Systems Engineering and Test teams from concept through commercial launch.
• Own the functional strategy, resource planning, and operating model for Systems Engineering to align with business priorities.
• Drive the adoption of improved engineering processes, tools, and best practices to strengthen organizational rigor.
• Manage system-level requirements, ensuring user needs are translated into traceable and risk-informed specifications.
• Collaborate cross-functionally with RA/QA, Product Management, and Operations to ensure design outputs meet regulatory and business needs.
• Provide technical leadership for regulatory inquiries, audits, and inspections.

Requirements

• BS in Systems, Electrical, or Biomedical Engineering (MS/MBA preferred).
• 15+ years of experience in regulated medical device development (Class II/III connected devices).
• 8+ years of people leadership managing multidisciplinary engineering teams.
• Deep expertise in systems engineering: requirements traceability, architecture definition, and interface control.
• Working knowledge of regulatory standards: FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.
• Proven track record in system-level risk management (dFMEA/pFMEA/uFMEA) and V&V strategy.

Nice to have

• Experience with cardiology, metabolic disease, or diagnostic technologies.
• Knowledge of AI-enabled tools and responsible-use practices within FDA-regulated environments.
• Professional certifications such as INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma.

Culture & Benefits

• Mission-driven environment focused on improving global cardiac health and patient care.
• Opportunities for rapid career advancement and professional growth.
• Inclusive workforce culture that celebrates diverse backgrounds and perspectives.
• Remote-first work flexibility for US-based employees.