Principal Software Quality Engineer, SaMD, Cybersecurity

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide independent oversight of quality for software development activities, ensuring adherence to SDLC procedures, design controls, and relevant regulatory requirements.

• Review and approve software development plans, requirements, architectural and design documentation, verification and validation protocols, test reports, and release documentation.

• Ensure traceability of requirements, configuration management, software risk management, and design controls throughout the product lifecycle.

• Assess software changes for their impact on patient safety, product effectiveness, cybersecurity, and regulatory submission obligations.

• Integrate risk-based quality controls within Agile development, DevSecOps, CI/CD pipelines, and automated testing methodologies.

• Supervise medical device cybersecurity initiatives, including threat modeling, security risk assessments, vulnerability analyses, and verification of cybersecurity risk controls.

• Ensure compliance with FDA cybersecurity standards, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, and other pertinent regulations.

• Manage Software Bills of Materials (SBOMs), third-party software components, vulnerability monitoring, patch management, and cybersecurity incident responses.

• Review cybersecurity testing evidence, including penetration testing, static and dynamic application security testing, and software composition analysis.

• Oversee software verification and validation processes, including unit, integration, system, regression, performance, and security testing.

• Support software and cybersecurity documentation necessary for FDA 510(k) submissions, international regulatory filings, audits, and inspections.

• Ensure the completeness, accuracy, and traceability of software Design History Files, risk management documentation, and QMS records.

• Lead or assist in nonconformance investigations, root cause analysis, CAPA, and the evaluation of complaints, defects, and postmarket cybersecurity vulnerabilities.

• Establish and track software quality metrics, including defect trends, test coverage, CAPA effectiveness, cybersecurity remediation, and release quality.

• Serve as a subject matter expert in software quality and cybersecurity, communicating risks and compliance status to management while driving continuous improvement.

⛳️ Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Cybersecurity, or a related technical field.

• At least 8 years of experience in software quality engineering, software development, software verification and validation, or related fields.

• A minimum of 5 years of experience with FDA-regulated medical devices, Software as a Medical Device (SaMD), digital health, or connected medical device software.

• Proven experience with IEC 62304, ISO 13485, ISO 14971, FDA design controls, and software risk management.

• Knowledge of medical device cybersecurity, secure software development, cybersecurity risk assessments, and vulnerability management.

• Familiarity with Agile software development, DevSecOps, CI/CD pipelines, automated testing, and software configuration management.

• Experience in supporting FDA regulatory submissions, software change assessments, audits, CAPA investigations, and regulatory inspections.

• Preferably experienced with cloud-based software, healthcare applications, or connected medical device systems.

• Advanced degree or relevant professional certifications, such as CISSP, CSSLP, CISM, ASQ CSQE, CQE, or applicable auditor certifications, are preferred.

• In-depth knowledge of medical device software quality engineering, software development lifecycle processes, design controls, and applicable FDA and international regulatory standards.

• Strong grasp of medical device cybersecurity standards, secure software development practices, and cybersecurity risk management.

• Proficient in software verification and validation, automated testing, requirements traceability, and configuration management.

• Familiarity with 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 abilities.

• Demonstrated capacity 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 capability to relay complex technical and regulatory information to diverse audiences.

• Strong organizational skills with the capability to manage multiple priorities in a dynamic software development environment.

• Detail-oriented, proactive, and accountable, with a commitment to continuous improvement, quality ownership, and sound professional judgment.

🏝️ Benefits

• Comprehensive medical, dental, and vision insurance.

• Financial planning assistance.

• Discounts on physical and mental wellness programs.

• Unlimited access to an online learning platform.

• Paid Time Off (hourly) / Flex Time Off (salaried) programs for Full-Time employees.

• Opportunities for Growth and Development.

• 401(k) plan with a 3% company match.

• Paid Holidays.

• Paid Parental Leave, including a flexible return-to-work program.

• Employee Assistance Program.

• Discounts available on popular cell phone plans.

• Life & Disability Insurance.