Principal Software Quality Engineer, SaMD, Cybersecurity

Stelle nicht auf LinkedIn

🕒 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 ein Softwareunternehmen im Gesundheitswesen, das klinische Überwachung und Lösungen zur Fernüberwachung von Patienten für Krankenhäuser und Pflegeteams anbietet. Seine herstellerunabhängige Plattform aggregiert und zeigt nahezu in Echtzeit Wellenformen, EKGs in diagnostischer Qualität (einschließlich 12-Kanal- und Kardiorhythmus-Streifen), Überwachung von Mutter und Fötus, Alarmmanagement und Alarmauswertung, Entscheidungsunterstützung sowie Telemetrieoptimierung über native mobile Apps und das Web an. Die Produkte von AirStrip sind für den Einsatz in den Workflows der Kardiologie, Geburtshilfe, Intensivpflege, Notfallmedizin und Telemetrie konzipiert; die Plattform betont die HIPAA-Compliance und branchenübliche Sicherheit (ISO 27001) für die klinische Integration mit EMRs und Geräten am Krankenbett. AirStrip wurde außerdem von TIME 2025 als eines der weltweit besten HealthTech-Unternehmen ausgezeichnet.

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 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 activities, 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 DHFs, 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 • 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 • 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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