Director, Systems Engineering

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iRhythm Technologies, Inc.

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2006

⚕️ Krankenversicherung

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical Technology

iRhythm Technologies, Inc. ist ein Unternehmen für Medizintechnologie, das sich auf Lösungen für die Herzüberwachung spezialisiert hat. Ihr Flaggschiffprodukt, der Zio-EKG-Monitor, ist auf Patientenkomfort und Einhaltung ausgelegt und ermöglicht es Gesundheitsdienstleistern, präzise Diagnosen von Herzrhythmusstörungen durch fortschrittliche Datenanalyse und KI zu liefern. Der umfassende Service von iRhythm transformiert das Erlebnis der Herzüberwachung, erleichtert bessere Patientenergebnisse und effiziente Arbeitsabläufe für Gesundheitsprofis weltweit.

Beschreibung

• Lead, develop, and mentor multidisciplinary Systems Engineering and Test teams supporting product development of cardiac diagnostic technologies from concept through commercial launch, as well as sustaining and lifecycle engineering activities. • Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering, ensuring alignment with business priorities and portfolio roadmaps. • Serve as an effective change agent by driving adoption of improved engineering processes, tools, and best practices while maintaining team engagement, compliance standards, and organizational momentum. • Lead system-level requirements management, ensuring user needs are translated into clear, testable, traceable, risk-informed product, system, subsystem, software, hardware, firmware, and verification requirements. • Communicate project status, risks, budget, resource needs, and execution priorities to executive leadership in a clear, concise, and actionable manner. • Provide leadership support of external vendor partnerships, engineering evaluations, and verification testing of design changes as required. • Partner cross-functionally with RA/QA, Product Management, Operations, Clinical, Manufacturing, and R&D functions to ensure design inputs and outputs meet regulatory, quality, customer, patient, user, and business needs. • Sponsor a Systems Engineering community of practice, bringing industry best practices, training, standards awareness, and engagement with the broader systems engineering community (INCOSE, AAMI, MDIC, etc). • Provide key planning inputs to ensure resource management, timelines, and budgets meet program and business needs. • Provide oversight and targeted participation in QMS improvement initiatives, including DOP/SOP authoring and maintenance, to help ensure engineering processes are robust, efficient, compliant, and executable. • Support regulatory inquiries, audits, inspections, and technical discussions, as required.

🎯 Anforderungen

• BS in Systems Engineering, Electrical Engineering, Biomedical Engineering or related engineering degree; MS/MBA a plus • 15+ years in regulated medical device development (Class II/III Connected) with deep experience in Systems Engineering across NPI and sustaining/lifecycle in regulated manufacturing environments. • 8+ years of people leadership managing and developing multidisciplinary engineering teams (Systems Engineering; HW/FW/SW/mechanical integration) • Expertise in systems engineering best practices: user needs → system/subsystem requirements, architecture, interface definition/control, requirements traceability, and configuration management. • Experience developing medical device platforms that include hardware, firmware and tools/fixtures that interface with devices and/or data in a safe and secure way. • Working knowledge of applicable regulatory standards and requirements, including FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 as applicable. • Proven leadership of system-level risk management and design change execution in medical device development, including hazard analysis, dFMEA/pFMEA/uFMEA, impact assessments, V&V/regulatory strategy alignment, and design transfer support. • Proven ownership of verification strategy and execution, including test planning, protocol/report oversight, coverage and traceability management, and ensuring robust evidence for product releases and design changes. • Strong executive communication and cross-functional leadership, including vendor/partner governance, prioritization across multiple programs, and structured problem-solving (RCA/CAPA support) • Experience supporting global regulatory submissions and responses, including FDA, EU MDR, and international submissions, with technical content and objective evidence.

🏖️ Vorteile

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options