2 days 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 risk management, software design controls, V&V processes, and complex quality initiatives across multiple products and 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 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 quality systems, development practices, automation, verification, validation, and compliance processes.
- Evaluate emerging regulations and standards and advise on product and quality strategy.
- Mentor software quality engineers and provide technical leadership to cross-functional development teams.
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 with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements.
- Advanced knowledge of software development lifecycle processes and methodologies, including Agile, Waterfall, DevOps, continuous integration, continuous delivery, and test automation.
- Deep software quality engineering experience across 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.
- 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, and executive-level communication skills, with the ability to manage ambiguity and influence senior stakeholders.
- Demonstrated success mentoring engineers and developing organizational quality capabilities.
Benefits
- Comprehensive benefits program.
- Global growth opportunities and access to in-house learning programs and qualified tuition reimbursement.
- Remote home-office workplace; hybrid work may be available for employees within commuting distance of a Dexcom site, with a Flex workplace option.
- The role requires 15–25% travel.
Categories
About Dexcom
Dexcom designs and manufactures continuous glucose monitoring (CGM) systems for people with diabetes, combining wearable sensors with transmitters, mobile apps, and cloud data services. It sells devices and disposable sensors through pharmacies, durable medical equipment channels, and healthcare providers, often covered by insurance. Founded in 1999 and headquartered in San Diego, Dexcom is a public company traded on NASDAQ (DXCM).