2 hours ago
Base Salary
$117k - $194k/yr
Responsibilities
- Serve as a technical leader and subject matter expert for software quality, risk management, and software lifecycle compliance.
- Lead software development, verification, validation, risk management, and software design-control processes.
- Lead complex software quality initiatives across multiple products, programs, and functional organizations.
- Conduct risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.
- Support ALM, SCM, and PLM digital transformation initiatives supporting the SDLC under IEC 62304.
- Provide technical oversight for DFMEA, PFMEA, SHA, and hazard-analysis activities.
- Review and approve software lifecycle documentation, risk artifacts, V&V protocols, and design history file content.
- Drive improvements in software quality systems, development practices, automation, verification, validation, and compliance.
- Evaluate regulations, standards, and industry trends and assess their impact on products.
- Define quality strategies and right-sized QMS applications based on software classification.
- Mentor software quality engineers and provide technical leadership to cross-functional development teams.
- Influence project, product, and organizational decisions through risk-based quality assessments and recommendations.
- Support regulatory inspections and interactions with the FDA, notified bodies, and external auditors.
Requirements
- Bachelor’s degree in a technical discipline and 8–12 years of related experience, or a master’s degree and 5–7 years of equivalent industry experience, or a PhD and 2–4 years of experience.
- Extensive medical-device experience and expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements.
- Advanced knowledge of software lifecycle processes and development methodologies, including Agile, Waterfall, DevOps, continuous integration, continuous delivery, and test automation.
- Deep software quality engineering experience spanning requirements, architecture, design, development, testing, release, and post-market activities.
- Advanced understanding of software risk-management principles, methodologies, and regulatory expectations.
- Ability to influence organizational direction and lead cross-functional initiatives without direct authority.
- Strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms.
- Experience supporting regulatory inspections and interacting with the FDA, notified bodies, and external auditors.
- Strong written, verbal, executive-level communication, ambiguity-management, stakeholder-influence, and complex-program execution skills.
- Demonstrated success mentoring engineers and developing organizational quality capabilities.
Benefits
- Remote home-office workplace; employees within approximately 75 miles/120 km of a Dexcom site may have a hybrid option.
- Flex workplace option may be available.
- Full and comprehensive benefits program.
- Global growth opportunities and career development through in-house learning programs and qualified tuition reimbursement.
- Approximately 15–25% travel required.
Categories
About Dexcom
Empowering People to Take Control of Health Dexcom Corporation (NASDAQ DXCM) has been a pioneer in glucose sensing for more than 25 years. Since 1999, we have developed innovative technologies that transformed how people manage diabetes. Our products are part of people’s daily lives, empowering them to live confidently and feel more in control, free to pursue their dreams. Headquartered in San Diego, California, with operations around the world, Dexcom leads by listening to the needs of users, caregivers, and providers, to simplify and improve glucose management.