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Lead Quality Assurance Engineer
2 months ago
About Dexcom:
Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM) specializes in the development and marketing of Continuous Glucose Monitoring (CGM) systems designed for use by individuals with diabetes and healthcare professionals. As a pioneer in diabetes care and management, Dexcom is committed to enhancing patient outcomes through innovative CGM technology, enabling better management of diabetes for both patients and clinicians. With a reported revenue of $2.9B in 2022, reflecting an 18% growth from the previous year, Dexcom is headquartered in San Diego, California, and employs over 8,000 individuals globally.
Join Our Team:
This department plays a crucial role in providing technical support and expertise to software teams, ensuring adherence to software development processes and relevant safety and quality system regulations (e.g., IEC 62304, ISO 13485). Our focus is on various aspects of Software Design Assurance, emphasizing product enhancement, new product development, and defect prevention. We collaborate with diverse cross-functional teams, including Software Engineering, Software Testing, Regulatory Affairs, Marketing, Project Management, and Systems Engineering, fostering a supportive team culture in a dynamic environment.
Key Responsibilities:
- Actively engage as a core member of the R&D Quality Assurance Engineering team.
- Provide guidance on IEC 62304, 21 CFR 820, and other global regulations to cross-functional teams.
- Lead the effective implementation, compliance, and continuous enhancement of policies, procedures, and practices related to software development and validation.
- Offer technical guidance regarding equipment, software, product, and process requirements, driving risk management deliverables such as SHA and design/process FMEA.
- Support Software Design and Test Teams in System validations, Software design verification, traceability, Software configuration management, tool validations, and software integrations.
- Assist in post-market activities related to Software anomalies, risk assessments, and CAPA activities as applicable.
- Review, author, revise, and approve technical documentation, including design history files, standard operating procedures, protocols, reports, and software design control deliverables.
- Evaluate the impact of change control to ensure product performance and compliance are maintained.
- Communicate effectively with the broader Dexcom team and upper management regarding plans, task status, project progress, and challenges.
- Perform additional duties as assigned.
Qualifications for Success:
- Experience with software mobile applications.
- Medical Device experience in compliance with FDA 21 CFR Part 820, IEC 62304, and ISO standards.
- Knowledge of SDLC processes and software development methodologies such as Agile and Waterfall.
- Experience in Software Quality or Engineering, including Requirements Analysis, Design/Development, Product Integration, and Testing.
- Ability to interpret software design and code to verify requirements implementation.
- Experience in Software development and/or Software testing.
- Capability to understand complex tasks and objectives, driving projects to completion with minimal supervision.
- Familiarity with web APIs.
- Strong communication skills to present to all management levels.
- Cyber Security experience is a plus.
- ASQ Certified Software Quality Engineer (CSQE) certification is desirable.
What We Offer:
- A unique opportunity to engage with life-changing CGM technology and learn about our dedicated #dexcomwarriors community.
- A comprehensive benefits program.
- Global growth opportunities.
- Access to career development through in-house learning programs and qualified tuition reimbursement.
- An innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Salary Information:
The annual base salary range for this role is $87,000 to $145,000. Final compensation will depend on factors such as relevant experience, skillset, knowledge, business needs, and market demand.Experience and Education:
- A Bachelor's degree in a technical discipline is typically required, along with 5-8 years of related experience, or a Master's degree with 2-5 years of equivalent industry experience, or a PhD with 0-2 years of experience.
Please note that the information provided is not an exhaustive list of the duties and responsibilities of the job, nor is it an all-inclusive list of the skills and abilities required. Management may assign or reassign duties and responsibilities at any time.
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.
