Senior Software Quality Assurance Manager (Medical Device / DHF Remediation) IRC304543

Description Project Overview The customer develops regulated medical-device systems used in clinical environments. These solutions include embedded diagnostic instruments, device firmware, connectivity components, web services, APIs, and cloud-hosted applications that process or store patient-related data.

We are looking for a Software Quality Assurance Senior Manager to lead the software quality organization and ensure that medical-device software is safe, reliable, fully verified, and compliant with applicable regulatory requirements.

Role Overview The Software Quality Assurance Senior Manager will lead the strategy, planning, and execution of software verification and validation across embedded, connected, and cloud-based medical-device solutions.

The role combines people management, software quality leadership, regulatory compliance, test automation, and cross-functional coordination. The successful candidate will ensure that software products and documentation are audit-ready and that quality practices support both product safety and efficient engineering delivery.

The manager will lead and mentor Software Development Engineers in Test and Software Quality Assurance Engineers.

Requirements Required Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
• At least 10 years of Software Quality Assurance experience.
• At least 7 years of leadership or management experience.
• Management experience within medical devices, healthcare technology, diagnostics, or another strongly regulated industry.
• Deep practical knowledge of IEC 62304.
• Strong experience working under ISO 13485 quality-management systems.
• Knowledge of FDA 21 CFR Part 11 and IVDR requirements.
• Demonstrated experience testing embedded software and firmware.
• Experience validating cloud-hosted applications and web-based APIs.
• Experience with hybrid edge-to-cloud system architectures.
• Proven ability to design, implement, and maintain automated test frameworks.
• Experience operating automated tests within regulated CI/CD environments.
• Strong knowledge of requirements-based testing and risk-based verification.
• Experience managing requirements-to-test and defect traceability.
• Understanding of cybersecurity principles and cybersecurity testing for connected products.
• Strong analytical, organizational, leadership, and problem-solving skills.
• Ability to translate technical and regulatory risks into clear business-relevant information.
• Excellent written and verbal English communication skills.

Technical Skills

• Test automation for embedded firmware and web-based APIs.
• Verification and validation of medical-device software.
• Requirements-based and risk-based testing.
• Software and system integration testing.
• Regression, performance, reliability, and cybersecurity testing.
• ALM and requirements-management systems.
• Jama Connect or comparable requirements-management tools.
• Jira or comparable issue and defect-tracking tools.
• CI/CD platforms such as Jenkins, GitLab CI/CD, or Azure DevOps.
• Test-result management and generation of controlled verification evidence.
• Configuration management and controlled software-release processes.

Preferred Qualifications

• Master’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field.
• Experience with point-of-care or in-vitro diagnostic devices.
• Experience testing software that processes or stores patient data.
• Experience with hospital-connected medical devices.
• Knowledge of ISO 14971 risk-management practices.
• Experience supporting FDA submissions, IVDR technical documentation, and regulatory inspections.
• Experience introducing automation into an organization with predominantly manual testing.
• Experience developing SDETs and building an automation-focused software-quality team.
• Experience validating cloud infrastructure and connected-device ecosystems.
• Familiarity with software bill of materials, vulnerability management, threat modeling, and secure software-development practices.
• Experience applying AI tools within controlled verification or quality processes.
• Expected Deliverables
• Software quality and V&V strategy.
• Risk-based master test plans.
• Approved verification protocols and test cases.
• Automated testing framework and automation roadmap.
• Require…