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Lead Software 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 aimed at enhancing the lives of individuals with diabetes and supporting healthcare providers in their treatment efforts. As a pioneer in diabetes care and management, Dexcom is committed to delivering top-tier CGM technology that empowers patients and healthcare professionals alike. With a reported revenue of $2.9B in 2022, reflecting an 18% growth from the previous year, Dexcom operates from its headquarters in San Diego, California, and has a global workforce exceeding 8,000 employees.
Join Our Team:The Software Quality Assurance Team at Dexcom plays a crucial role in various dimensions of Quality Engineering, including the management of specific elements of the quality system. As a Lead Software Quality Assurance Engineer, you will collaborate with numerous internal departments such as Quality Assurance, Research & Development, Software Development, Operations, Engineering, Regulatory Affairs, Clinical Affairs, Human Factors, Product Management, Legal, Finance, Customer Operations, Technical Support, and senior management. Success in this position requires a systematic approach, exceptional organizational skills, clear communication, technical expertise, and the ability to thrive in a collaborative environment. A positive mindset is essential in our dynamic workplace, where priorities frequently shift.
Your Responsibilities:- This role does not involve executing software testing; it is not a testing position.
- Ensure that product software and software development processes adhere to relevant safety and quality system regulations and standards.
- Guide teams in the execution of Software Life Cycle and design control activities.
- Lead risk management initiatives to enhance product safety and efficacy.
- Facilitate teams in identifying, documenting, assessing, correcting, and preventing quality issues through risk analysis and root cause analysis, from initial product concept to design transfer and post-market surveillance.
- Identify and drive process improvement initiatives, including the design, updating, and application of company policies and procedures to align with quality objectives and regulatory compliance.
- Participate in Cybersecurity risk assessments.
- Act as a technical quality representative for mobile app teams.
- Contribute to defining design inputs, designing components and processes, and verifying that design outputs meet design inputs, while guiding R&D teams through a risk-based design approach.
- Engage in health hazard assessments for product field issues.
- A minimum of a Bachelor's degree with 6+ years of relevant experience; advanced degrees with fewer years of experience may be considered.
- Experience in the medical device industry or other regulated sectors is preferred.
- Familiarity with compliance requirements of FDA 21 CFR Part 820, IEC 62304, and ISO 13485.
- Extensive knowledge of SDLC processes and software development methodologies, including Agile and Waterfall.
- Experience in Software Quality and/or Engineering, particularly in Requirements Analysis, Design/Development, Product Integration, and Testing.
- Ability to interpret software design and code to verify compliance with requirements.
- Capability to work effectively in a fast-paced environment, manage complex tasks, and drive projects to completion with minimal supervision.
- Strong written and verbal communication skills, with experience presenting to various management levels.
- Understanding of mobile device operating systems, including applications, internet connectivity, and Bluetooth communication.
- ASQ Certified Software Quality Engineer is a plus.
- A unique opportunity to be at the forefront of life-changing CGM technology.
- A comprehensive benefits package.
- Opportunities for growth on a global scale.
- Access to career development through in-house learning programs and tuition reimbursement.
- Be part of an innovative organization dedicated to its employees, customers, and the communities we serve.
- 15-25% travel may be required.
- A Bachelor's degree in a technical field 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 here is not an exhaustive list of the duties and responsibilities associated with this position, nor is it a comprehensive list of the skills and abilities required. Management may assign or reassign duties and responsibilities at its discretion.
Dexcom is 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 based on disability.
