Job description

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, including defect trends, test coverage, CAPA effectiveness, cybersecurity remediation, and release quality. Serve as a software quality and cybersecurity subject matter expert, communicating risks, compliance status, and quality performance to management while driving continuous improvement. Education & Experience Requirements: 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. Required Knowledge, Skills, and Abilities: 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 software development and collaboration tools such as 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. This is a salaried, exempt position. The annual salary range for applicable U.S.-based applicants to this position is $161,000–$196,000. The specific salary will depend on the successful candidate’s qualifications, prior experience, and geographic location. We value each of our employee’s total wellness. From robust medical, dental, and vision insurance, to financial planning assistance, to physical and mental wellness discounts, and unlimited access to our online learning platform, we understand that our company succeeds when our employees succeed as individuals. Additional notable US-employee benefits include: 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 And more! AirStrip provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Requirements

Must-haves

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, including defect trends, test coverage, CAPA effectiveness, cybersecurity remediation, and release quality.
Serve as a software quality and cybersecurity subject matter expert, communicating risks, compliance status, and quality performance to management while driving continuous improvement.
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.

Nice-to-haves

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.

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

agileci/cdjiraazure

Platform: dayforce
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401(K)

Paid Time Off

Parental Leave

Wellness