[Hiring] Software QA Engineer 2 @Dexcom

Role Description

You will actively participate as a core team member of the R&D Quality Assurance Engineering team.

• Provide guidance on IEC 62304, 21 CFR 820, ISO 14971, and other relevant regulations worldwide to the cross-functional teams.
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams.
• Provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA.
• Support Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations, and software integrations.
• Support post market activities related to Software anomalies, risk assessments, and CAPA activities (if applicable).
• Review, author, revise, and approve appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables.
• Assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained.
• Effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress, and challenges.
• Assume and perform other duties as assigned.

Qualifications

• Experience working with software mobile applications.
• Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model.
• Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration, and Test.
• Proficiency to interpret software design and code to verify implementation of requirements.
• Software development and/or Software test experience.
• Ability to understand complex tasks and goals.
• Drive projects to completion with limited supervision.
• Ability to communicate and present to all levels of management.

Requirements

• Nice to have knowledge of Cyber Security.
• Nice to have ASQ Certified Software Quality Engineer (CSQE) certification or equivalent.
• Nice to have Jama, Jira, Kettryx, and/or Test Rails experience.

Benefits

• 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.

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.