Staff Software Quality Assurance Engineer

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

📋 Description

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

• Oversee application, compliance, and ongoing enhancement of software development and verification and validation (V&V) processes, including risk management and software design controls for Class I/II exempt applications and components.

• Lead intricate software quality projects that span multiple products, programs, and functional areas.

• Conduct risk assessments for software anomalies, cybersecurity threats, new technologies, and post-market concerns.

• Support digital transformation efforts involving Application Lifecycle Management (ALM), Software Configuration Management (SCM), and Product Lifecycle Management (PLM) systems in accordance with IEC 62304.

• Provide technical guidance and oversight for software risk management activities, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), Software Hazard Analysis (SHA), and hazard evaluation.

• Review and authorize key quality deliverables, such as software lifecycle documentation, risk artifacts, V&V protocols, and design history file content.

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

• Assess new regulations, standards, and industry trends to evaluate their implications on current and future products.

• Work in collaboration with senior leadership to establish quality strategies that align with business objectives and product roadmaps.

• Implement appropriately scaled Quality Management System (QMS) applications based on software classification as per IEC 62304.

• Mentor and offer technical leadership to software quality engineers and cross-functional development teams.

• Impact project, product, and organizational decisions through expert risk-based quality evaluations and recommendations.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

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

• Extensive experience in the medical device industry.

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

• Advanced understanding of software development lifecycle processes and methodologies, including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation.

• Significant experience in software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities.

• Advanced comprehension of software risk management principles, methodologies, and regulatory expectations.

• Ability to shape organizational direction and lead cross-functional initiatives without direct authority.

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

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

• Outstanding written, verbal, and executive-level communication skills.

• Capability to manage uncertainty, influence senior stakeholders, and successfully drive complex programs to completion.

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

🏝️ Benefits

• A comprehensive and inclusive benefits program.

• Opportunities for growth on a global scale.

• Access to career development through in-house training programs and/or eligible tuition reimbursement.

• Flexible home office arrangements.

• Potential for flexible workplace options for employees within commuting distance of a Dexcom location.

• Travel opportunities ranging from 15–25%.