Want to know if this job is worth applying to?
United States
Remote only
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
Provides technical leadership for software quality assurance activities, including risk management activities following ISO 14971, with a focus on IOT Infrastructure, Data Platforms and Digital Health Applications. 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 Class I/II Exempt Digital Health Applications and supporting IOT Infrastructure platforms, risk management, and regulatory compliance.
Where you come in:
Develop and drive enterprise-level software quality strategies, policies, procedures, and best practices across the Non-Clinical – Consumer Applications and Digital Health space, including platforms.
Serve as a technical leader and subject matter expert for software quality, risk management, software lifecycle compliance activities and GxP Non-Product Tools supporting SDLC.
Lead the effective application, compliance, and continuous improvement of software development and V&V processes, including:
Risk Management
GxP Systems Validation
Software Design Controls for Class I/II Exempt Applications & Components
Lead complex software quality initiatives spanning multiple products, programs, and functional organizations.
Lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.
Lead digital transformation initiatives (ALM, SCM, PLM) to evolve use of electronic systems supporting SDLC as defined per IEC62304.
Provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis.
Review and approve critical quality deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content.
Drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes.
Evaluate emerging regulations, standards, and industry trends and assess impact to existing and future products.
Collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps, implementing a right-sized QMS for Non-Clinical applications.
Mentor and provide technical leadership to software quality engineers and cross-functional development teams.
Influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations.
What makes you successful:
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.
Expert 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.
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:
15-25%
Experience and Education Requirements:
Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience of a PhD and 5+ 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
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$135,100.00 - $225,100.00