Principal Software Quality Engineer, SaMD, Cybersecurity

AirStrip

. Provide independent quality oversight of software development activities, ensuring compliance with SDLC procedures, design controls, and applicable regulatory requirements .

Posted 10/24/2026full-timeRemote • United StatesLead💰 $161,000 - $196,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in software quality engineering and cybersecurity for medical devices, ensuring compliance with FDA regulations and international standards. Proficient in risk management, verification and validation processes, and Agile methodologies to enhance product safety and effectiveness.

Highest-signal resume keywords

Software Quality EngineeringMedical Device CybersecurityFDA Regulatory SubmissionsAgile DevelopmentRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Verification and ValidationRequirements TraceabilityConfiguration ManagementAutomated TestingCybersecurity Risk AssessmentsVulnerability ManagementDesign ControlsSoftware Development LifecycleCloud-Based SoftwareHealthcare Applications

Soft Skills

Analytical SkillsProblem-SolvingCommunication SkillsOrganizational SkillsCritical Thinking

Tools & Technologies

JiraAzure DevOpsGitHubGitLab

Certifications & Qualifications

CISSPCSSLPCISMASQ CSQECQE

Industry Keywords

FDA Design ControlsIEC 62304ISO 13485ISO 14971Software as a Medical DeviceDigital HealthConnected Medical Device SoftwareCybersecurity StandardsCAPASoftware Bills of Materials

Tech Stack

Tools & technologies

AzureCloudCyber SecuritySDLC

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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