Staff Software QA Engineer

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

📋 Description

• Act as a technical leader and a subject matter expert in software quality, risk management, and compliance within the software lifecycle.

• Oversee the application, compliance, and ongoing enhancement of software development and verification & validation (V&V) processes, with a focus on risk management and software design controls.

• Direct complex software quality initiatives that encompass multiple products, programs, and functional areas.

• Conduct risk assessments addressing software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market challenges.

• Assist with digital transformation projects relating to Application Lifecycle Management (ALM), Software Configuration Management (SCM), and Product Lifecycle Management (PLM) systems that support the Software Development Life Cycle (SDLC) under IEC 62304.

• Offer technical oversight and guidance for Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), Software Hazard Analysis (SHA), and hazard evaluations.

• Review and authorize software development lifecycle documentation, risk-related artifacts, V&V protocols, and content within design history files.

• Propel enhancements in software quality systems, development practices, automation, verification, validation, and compliance processes.

• Assess emerging regulations, standards, and industry trends, evaluating their implications for products.

• Work in collaboration with senior leadership to establish quality strategies and implement appropriately scaled Quality Management System (QMS) applications based on IEC 62304 software classifications.

• Mentor software quality engineers and cross-functional development teams.

• Shape project, product, and organizational decisions through risk-informed quality assessments and recommendations.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in a technical field with 8–12 years of relevant experience, or a Master’s degree with 5–7 years of equivalent experience in the industry, or a PhD with 2–4 years of experience.

• Significant experience in the medical device sector.

• Proven expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and relevant global regulatory standards.

• Advanced knowledge of software development lifecycle processes alongside Agile, Waterfall, DevOps, CI/CD, and test automation methodologies.

• Extensive background in software quality engineering throughout requirements, architecture, design, development, testing, release, and post-market activities.

• In-depth understanding of software risk management principles, methodologies, and regulatory expectations.

• Capability to influence organizational direction and lead cross-functional initiatives without direct authority.

• Strong knowledge of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms.

• Experience in supporting regulatory inspections and engaging with the FDA, notified bodies, and external auditors.

• Excellent written, verbal, and executive-level communication abilities.

• Capacity to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion.

• Proven success in mentoring engineers and enhancing organizational quality capabilities.

• Willingness to travel 15–25% of the time.

🏝️ Benefits

• A comprehensive and robust benefits package.

• Opportunities for growth on a global scale.

• Access to career development through internal learning programs and/or eligible tuition reimbursement.

• Option to work from home.

• Flexible workplace options may be available.

• A front-row seat to transformative Continuous Glucose Monitoring (CGM) technology.

• Join an exciting, innovative, and industry-leading organization dedicated to its employees, customers, and communities.