Are you ready to link your passion with a purpose? At AirStrip, we build technology that enables clinicians to diagnose earlier than ever before, accelerate life-saving interventions, reduce the cost of care, and save lives.
We provide mobile-first clinical surveillance and alarm communication management technology that unlocks siloed data from patient monitors and transforms it into contextually rich information easily accessible on mobile devices and the Web. We’re seeking innovative thinkers who love doing meaningful work. If you’re looking to bring your skills and expertise to a growing technology company, it’s time for you to join us!
AirStrip is adding a Principal Software Quality Engineer, SaMD and Cybersecurity to our Quality Assurance and Regulatory Affairs team. In this role, you’ll provide technical leadership and independent quality oversight of software development, cybersecurity, verification, validation, and release activities for Software as a Medical Device (SaMD) and connected medical device software products.
You’ll collaborate closely with Development, Engineering, Cybersecurity, and Regulatory Affairs teams to integrate quality, risk management, and cybersecurity controls throughout the software development lifecycle. As a subject matter expert, you’ll help ensure regulatory compliance, strengthen software quality processes, and support the delivery of safe, secure, and reliable healthcare technology.
This is a remote position requiring up to 30% travel to company office locations.
Responsibilities include, but are not limited to:
Provide independent quality oversight of software development activities, ensuring compliance with established Software Development Life Cycle (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 appropriate requirements traceability, configuration management, software risk management, and design controls throughout the product lifecycle.
Evaluate software changes for potential impacts on patient safety, product effectiveness, cybersecurity, and regulatory submission requirements.
Partner with cross-functional teams to integrate risk-based quality controls into Agile development, DevSecOps, continuous integration and continuous delivery (CI/CD) pipelines, and automated testing processes.
Provide quality oversight of medical device cybersecurity activities, including threat modeling, security risk assessments, vulnerability analyses, and verification of cybersecurity risk controls.
Ensure compliance with applicable FDA cybersecurity requirements, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, and other relevant industry standards.
Oversee adherence to established processes for 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 activities, including unit, integration, system, regression, performance, and security testing, ensuring adequate risk-based test coverage and release readiness.
Support preparation and review of software and cybersecurity documentation for FDA 510(k) submissions, international regulatory filings, audits, and regulatory inspections.
Ensure completeness, accuracy, and traceability of software Design History Files (DHF), risk management documentation, and applicable Quality Management System (QMS) records.
Lead or support software-related nonconformance investigations, root cause analysis, Corrective and Preventive Actions (CAPA), and evaluation of product complaints, defects, and postmarket cybersecurity vulnerabilities.
Establish and monitor software quality metrics,…