Meet the team:
Provides technical expertise for software quality assurance activities, including risk management activities following ISO 14971. Supports the development and implementation of scalable quality systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance. Partners with senior R&D engineering, quality, regulatory, clinical, cybersecurity, and business leaders to drive continuous improvements to SDLC, and quality excellence throughout the product lifecycle. Influences organizational quality strategy and serves as a recognized subject matter expert in software quality.
Where you come in:
- 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.
What makes you successful:
- You have 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.
- You have advanced knowledge of software development lifecycle processes and software development methodologies including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation.
- You have deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities.
- You have advanced understanding of software risk management principles, methodologies, and regulatory expectations.
- You have demonstrated ability to influence organizational direction and lead cross-functional initiatives without direct authority.
- You have strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms.
- You have experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors.
- You have exceptional written, verbal, and executive-level communication skills.
- You have the ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion.
- You have demonstrated success mentoring engineers and developing organizational quality capabilities.
What you’ll get:
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- 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.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
Experience and Education Requirements:
- 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.
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.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.
Salary:
$116,600.00 - $194,400.00
