Principal Software Quality Engineer, SaMD, Cybersecurity

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🕒 vor 6 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $161.000 - $196.000 / Jahr

⏰ Vollzeit

🔴 Experte

🔧 QA-Ingenieur (Qualitätssicherung)

👻 Geisterscore 0%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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AirStrip

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2006

🏥 Gesundheitswesen

☁️ SaaS

💰 €50.000.000 Debt Financing - Airstrip Technologies im 2025-10

Healthcare • SaaS

AirStrip ist eine herstellerunabhängige Plattform für klinisches Überwachungs- und Patientenmanagement, die Echtzeit-Wellenformen, EKGs, Alarme und andere klinische Daten von Monitoren, elektronischen Patientenakten (EPAs) und medizinischen Geräten aggregiert und diese über mobile und Web-Anwendungen an Kliniker liefert. Zu den Produkten von AirStrip gehören Lösungen für die Patientenüberwachung, Geburtshilfe (mütterliche/fötale Überwachung), Kardiologie (12-Kanal-EKGs, STEMI-Benachrichtigungen), Alarmmanagement und Analytik, Telemetrie-Optimierung und Entscheidungsunterstützung. Die Plattform betont den nahezu in Echtzeit erfolgenden Zugriff auf Wellenformen, Alarmtriage/-weiterleitung, die Erfassung von EKGs in Diagnosequalität und die sichere Übertragung von elektronischen Patientenakten und erfüllt die Sicherheitsanforderungen der Industrie sowie HIPAA-Vorgaben.

Beschreibung

• Provide independent quality oversight of software development activities, ensuring compliance with SDLC procedures, design controls, and applicable regulatory requirements • Review and approve software development plans, requirements, architecture and design documentation, verification and validation protocols, test reports, and release documentation • Ensure requirements traceability, configuration management, software risk management, and design controls throughout the product lifecycle • Evaluate software changes for impacts on patient safety, product effectiveness, cybersecurity, and regulatory submission requirements • Integrate risk-based quality controls into Agile development, DevSecOps, CI/CD pipelines, and automated testing processes • Oversee medical device cybersecurity activities, including threat modeling, security risk assessments, vulnerability analyses, and verification of cybersecurity risk controls • Ensure compliance with FDA cybersecurity requirements, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, and other relevant standards • Oversee Software Bills of Materials (SBOMs), third-party software components, vulnerability monitoring, patch management, and cybersecurity incident response • Review cybersecurity testing evidence, including penetration testing, static and dynamic application security testing, and software composition analysis • Oversee software verification and validation, including unit, integration, system, regression, performance, and security testing • Support software and cybersecurity documentation for FDA 510(k) submissions, international regulatory filings, audits, and inspections • Ensure completeness, accuracy, and traceability of software Design History Files, risk management documentation, and QMS records • Lead or support nonconformance investigations, root cause analysis, CAPA, and evaluation of complaints, defects, and postmarket cybersecurity vulnerabilities • Establish and monitor software quality metrics, including defect trends, test coverage, CAPA effectiveness, cybersecurity remediation, and release quality • Serve as a software quality and cybersecurity subject matter expert, communicate risks and compliance status to management, and drive continuous improvement

🎯 Anforderungen

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Cybersecurity, or a related technical discipline • Minimum of 8 years of experience in software quality engineering, software development, software verification and validation, or related disciplines • Minimum of 5 years of experience working with FDA-regulated medical devices, Software as a Medical Device (SaMD), digital health, or connected medical device software • Demonstrated experience with IEC 62304, ISO 13485, ISO 14971, FDA design controls, and software risk management • Experience with medical device cybersecurity, secure software development, cybersecurity risk assessments, and vulnerability management • Experience with Agile software development, DevSecOps, CI/CD pipelines, automated testing, and software configuration management • Experience supporting FDA regulatory submissions, software change assessments, audits, CAPA investigations, and regulatory inspections • Experience with cloud-based software, healthcare applications, or connected medical device systems preferred • Advanced degree or relevant professional certifications, such as CISSP, CSSLP, CISM, ASQ CSQE, CQE, or applicable auditor certifications, preferred • Advanced knowledge of medical device software quality engineering, software development lifecycle processes, design controls, and applicable FDA and international regulatory requirements • Strong understanding of medical device cybersecurity standards, secure software development practices, and cybersecurity risk management • Proficiency in software verification and validation, automated testing, requirements traceability, and configuration management • Working knowledge of Jira, Azure DevOps, GitHub, and GitLab • Understanding of cloud-based architectures, APIs, network security, third-party software, and healthcare interoperability technologies • Strong analytical, critical thinking, problem-solving, and risk-based decision-making skills • Demonstrated ability to provide technical leadership and influence cross-functional teams without direct reporting authority • Ability to balance regulatory compliance, patient safety, cybersecurity considerations, and business objectives • Excellent written and verbal communication skills, including the ability to communicate complex technical and regulatory information to diverse audiences • Strong organizational skills with the ability to manage multiple priorities in a fast-paced software development environment • Detail-oriented, proactive, and accountable, with a commitment to continuous improvement, quality ownership, and sound professional judgment

🏖️ Vorteile

• Robust medical, dental, and vision insurance • Financial planning assistance • Physical and mental wellness discounts • Unlimited access to online learning platform • Paid Time Off (hourly) / Flex Time Off (salaried) programs for Full Time employees • Growth and Development opportunities • 401(k), including a 3% company match • Paid Holidays • Paid Parental Leave, including a flexible return-to-work program • Employee Assistance Program • Discounts on popular cell phone plan providers • Life & Disability Insurance

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