Note: The job is a remote job and is open to candidates in USA. Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), dedicated to improving human health. The Staff SW QA Engineer will provide technical expertise in software quality assurance, lead compliance initiatives, and drive continuous improvements in software development processes.
Responsibilities
- You will serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities
- You will lead the effective application, compliance, and continuous improvement of software development and V&V processes, including: Risk Management, Software Design Controls for Class I/II Exempt Applications & Components
- You will lead complex software quality initiatives spanning multiple products, programs, and functional organizations
- You will lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues
- You will support digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined per IEC62304
- You will provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis
- You will review and approve critical quality deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content
- You will drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes
- You will evaluate emerging regulations, standards, and industry trends and assess impact to existing and future products
- You will collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps, implementing a right-sized QMS applications based on Software Classification per IEC62304
- You will mentor and provide technical leadership to software quality engineers and cross-functional development teams
- You will influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations
- You will assume and perform other duties as assigned
Skills
- Extensive medical device experience demonstrated 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 development lifecycle processes and software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation
- Deep experience with 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
- Demonstrated 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 direct interactions with FDA, notified bodies, and external auditors
- Exceptional written, verbal, and executive-level communication skills
- Ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion
- Demonstrated success mentoring engineers and developing organizational quality capabilities
- Typically requires a Bachelor's Degree in a technical discipline and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience
Benefits
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
- If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
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