Meet the team:The Customer Advocacy Engineering team transforms post-market insights into actions that enhance product safety, performance, and patient experience. In close partnership with R&D, Quality, Clinical, and Regulatory, the team identifies product trends, leads complex investigations, and ensures learnings are translated into improvements across both sustaining products and new product development.
Where you come in: - Support software quality activities related to post-market product performance, customer complaints, software anomalies, and product investigations.
- Conduct technical investigations of software-related issues using complaint data, field intelligence, logs, and engineering analysis to identify potential root causes and quality trends.
- Partner with cross-functional teams including R&D, Systems Engineering, Quality, Regulatory Affairs, Clinical Affairs, and Risk Management to evaluate software defects and their potential impact to product safety and performance.
- Support CAPA investigations, product performance assessments, and verification activities associated with software quality improvements.
- Analyze post-market data and product performance trends to identify opportunities for product, process, and quality system improvements.
- Collaborate with development and test engineering teams to ensure software defects are appropriately documented, investigated, prioritized, and resolved.
- Assist in maintaining compliance with product development processes, quality system requirements, and applicable regulatory standards throughout the product lifecycle.
- Participate in design reviews, defect triage discussions, and quality planning activities for new product development and sustaining engineering efforts.
What makes you successful: - Experience working with software products in a regulated environment, preferably medical devices, healthcare technology, or related industries.
- Working knowledge of software development lifecycle (SDLC), software quality engineering principles, and defect management processes.
- Familiarity with risk management processes and standards, including hazard analysis and risk assessment methodologies.
- Understanding of FDA Quality System Regulation (21 CFR Part 820), IEC 62304, ISO 13485, ISO 14971, or similar quality and regulatory frameworks.
- Strong analytical and problem-solving skills with the ability to evaluate complex technical issues and identify actionable solutions.
- Ability to interpret software requirements, test results, investigation findings, and customer feedback to support quality decisions.
- Effective communication and collaboration skills with the ability to work across multiple technical and business functions.
- Experience working with data analysis tools, defect tracking systems, and quality management systems.
- Nice to have experience with cybersecurity, software verification and validation, failure analysis, or complaint handling processes.
- Nice to have ASQ Certified Software Quality Engineer (CSQE) certification.
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: Experience and Education Requirements: - Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent 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.
Salary:
$78,900.00 - $131,500.00
