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Über
Dexcom has been dedicated to forever changing how diabetes is managed and is now broadening its vision beyond diabetes to empower people to take control of health with personalized, actionable insights aimed at solving important health challenges.
Meet The Team This functional department provides technical support and guidance to the Software teams to ensure conformance to software development process and applicable safety and quality system regulation and standards such as IEC 62304, ISO 13485, ISO 14971, 21 CFR 820.
The team focuses on Software Design Assurance with a view to product improvement, new product development, and defect prevention while collaborating with cross‑functional groups including Software Engineering, Software Test, Regulatory Affairs, Marketing, Project Management, System Engineering, Clinical, and others.
Where You Come In
You will actively participate as a core team member of the R&D Quality Assurance Engineering team.
You will provide guidance on IEC 62304, 21 CFR 820, ISO 14971, and other relevant regulations worldwide to cross‑functional teams.
You will lead the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams.
You will provide technical guidance with respect to equipment, software, product, process requirements and drive risk management deliverables such as SHA, design FMEA, and process FMEA.
You will advise Software Design and Test Teams for System validations, software design verification and traceability, software configuration management, tool validations, and software integrations.
You will support post‑market activities related to software anomalies, risk assessments, and CAPA activities (if applicable).
You will be responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, SOPs, protocols, reports, and software design control deliverables.
You will assess the impact of change control to ensure no adverse impact on product performance and maintain compliance status.
You will effectively communicate with the broader Dexcom team and upper‑level management regarding plans, status of tasks, project progress, and challenges.
You will assume and perform other duties as assigned.
What Makes You Successful
Experience working with software mobile applications.
Medical device experience in compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.
Knowledge of SDLC processes and software development methodologies such as Agile and Waterfall.
Software quality or engineering experience in Requirements Analysis, Design/Development, Product Integration, and Test.
Proficiency in interpreting software design and code to verify implementation of requirements.
Software development and/or software test experience.
Adept at understanding complex tasks and goals, driving projects to completion with limited supervision.
Strong communication and presentation skills at all levels of management.
Nice to have: knowledge of cybersecurity.
Nice to have: ASQ Certified Software Quality Engineer (CSQE) or equivalent certification.
What You’ll Get
A front‑row seat to life‑changing CGM technology and access to the Dexcom warriors 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, innovative, industry‑leading organization committed to employees, customers, and communities.
Travel Required
0–5%
Experience and Education Requirements
Typically requires a Bachelor’s degree in a technical discipline and a minimum of 2–5 years related experience, or a Master’s degree with 0–2 years equivalent 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/120 km).
If you reside within commuting distance, a hybrid working environment may be available.
Please ask about our Flex workplace option.
Salary $75,200.00 – $125,300.00
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.
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Sprachkenntnisse
- English
Hinweis für Nutzer
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