Senior Staff Software QA Engineer

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

📋 Description

• Provides technical leadership in software quality assurance activities, focusing on risk management in accordance with ISO 14971, particularly for Product Model and Clinical Applications.

• Aids in developing and implementing scalable quality systems, risk management practices, and software compliance strategies that guarantee product safety, efficacy, and adherence to regulatory standards.

• Collaborates with senior R&D engineering, Quality, Regulatory, Clinical, Cybersecurity, and business leaders to enhance the SDLC and promote quality excellence throughout the product lifecycle.

• Shapes the organizational quality strategy and acts as a recognized subject matter expert in Clinical product portfolio, risk management, and regulatory compliance support.

• Formulates and drives enterprise-level software quality strategies, policies, procedures, and best practices across Clinical Applications and Hospital sectors.

• Functions as a technical leader and subject matter expert in software quality, risk management, and software lifecycle compliance activities.

• Oversees the effective application, compliance, and continual improvement of software development and V&V processes, including Risk Management, Product model, Clinical support, and Software Design Controls.

• Directs complex software quality initiatives that span multiple products, programs, and functional organizations.

• Manages risk assessments concerning software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.

• Leads digital transformation initiatives (ALM, SCM, PLM) to enhance the use of electronic systems in support of the SDLC as defined by IEC62304.

• Provides technical oversight and guidance for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis.

• Reviews and approves critical quality deliverables, such as software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content.

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

• Assesses emerging regulations, standards, and industry trends and evaluates their impact on existing and future products.

• Works with senior leadership to establish quality strategies that align with business objectives and product roadmaps, implementing an appropriately sized QMS for Non-Clinical applications.

• Mentors and provides technical guidance to software quality engineers and cross-functional development teams.

• Influences project, product, and organizational decisions through expert risk-based quality assessments and recommendations.

⛳️ Requirements

• Extensive experience in the medical device field, showcasing expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and relevant global regulatory requirements.

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

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

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

• Proven ability to influence 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 engaging directly with FDA, notified bodies, and external auditors.

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

• Capability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful conclusion.

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

🏝️ Benefits

• A front row seat to life-changing CGM technology.

• Learn about our courageous #dexcomwarriors community.

• A comprehensive and extensive benefits program.

• Opportunities for growth on a global scale.

• Access to career development via in-house learning programs and/or qualified tuition reimbursement.

• An exciting and innovative, industry-leading organization dedicated to our employees, customers, and the communities we serve.