Sr Software Design Assurance Engineer
San Diego, CA - USA
Job Summary
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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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:
*This is not a test role*
At Dexcom our Software QA Engineering team plays a critical role in delivering life-changing continuous glucose monitoring (CGM) technology to people around the world. This role sits at the intersection of firmware and algorithm working closely with cross-functional partners to ensure our embedded systems meet the highest standards of quality safety and performance expected in medical devices.
Youll join a driven and highly collaborative team that values curiosity ownership and design excellence. We are deeply engaged with firmware and algorithm development teams contributing early and often throughout the product lifecycle. If you enjoy solving complex problems learning new technologies and making a real impact on patient outcomes this is the place for you.
Where you come in:
- You bring a strong understanding of IECCFR Part 820 and other global regulatory requirements and provide guidance to ensure compliance across software development activities.
- You partner closely with firmware algorithm and cross-functional teams to deliver high-quality embedded software for medical devices.
- You serve as a core team member representing Software QA contributing throughout the product lifecycle.
- You lead and influence the effective application compliance and continuous improvement of software development and validation processes.
- You provide guidance on software design testing configuration management tool validation and system integration.
- You lead and support pre-market and post-market risk management activities including software anomalies risk assessments and CAPA.
- You actively participate in design reviews requirements analysis and cross-functional discussions to drive quality upstream.
- You contribute to verification and validation activities across the SDLC with a strong focus on risk-based testing strategies.
- You review and approve software design control deliverables and author key technical documentation (e.g. DHF artifacts SOPs protocols and reports).
- You assess change control impacts to ensure continued product performance and compliance.
- You will assume and perform other duties as assigned.
What makes you successful:
- You bring experience in software quality or engineering across requirements analysis design/development product integration and testing.
- You can interpret software design and code to verify accurate implementation of requirements.
- You have hands-on experience in software development and/or software testing.
- You communicate effectively and confidently present to all levels of the organization.
- You are able to navigate complex problems break them down and drive projects to completion with minimal supervision.
- You have experience working with embedded systems and firmware including hardware/software integration and lab-based testing environments.
- You have experience in regulated industries (preferably medical devices) and are familiar with design controls V&V and quality systems (e.g. FDA 21 CFR Part 820 IEC 62304 ISO 13485).
- You are knowledgeable in SDLC processes and modern development methodologies such as Agile and Waterfall.
- You collaborate effectively with cross-functional teams and clearly communicate complex technical concepts.
- You bring a driven hands-on approach with a curiosity to learn new technologies and a focus on delivering high-quality outcomes.
- You must be able to support San Diego CA (PST) business hours
Nice to have:
- You hold an ASQ Certified Software Quality Engineer (CSQE) certification.
- You have experience with continuous glucose monitoring (CGM) systems or wearable medical devices.
- You bring a background in signal processing and experience validating algorithm-driven systems.
- You are familiar with real-time operating systems (RTOS) and embedded development environments.
- You have experience with continuous integration and continuous deployment (CI/CD) pipelines for embedded systems.
- You have experience using requirements management tools such as Jama.
What youll get: (this section should not be modified)
- 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:
- 0-5%
Experience and Education Requirements:
Typically requires a Bachelors degreein a technical discipline and a minimum
of 5-8 years related experience orMasters degree and 2-5 yearsequivalent industry experience or a PhDand 0-2 years experience
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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at
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
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: 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:
$95900.00 - $159900.00Required Experience:
Senior IC
About Company
Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.†