Software QA Engineer 2

Summary

Dexcom is a global continuous glucose monitoring and health technology company. The Software QA Engineer 2 will support software quality assurance for medical device software by guiding regulatory compliance, software validation, risk management, design controls, documentation, and post-market activities.

Responsibilities

• 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 the cross-functional teams
• You will lead in 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 driving risk management deliverables like SHA, design and process FMEA
• You will provide guidance to 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 are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables
• You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained
• You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges
• You will assume and perform other duties as assigned

Skills

• You have experience working with software mobile applications
• You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971
• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model
• Your Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Your proficiency to interpret software design and code to verify implementation of requirements
• You have Software development and/or Software test experience
• Your ability to understand complex tasks and goals. Drive projects to completion with limited supervision
• Your ability to communicate and present to all levels of management
• 0-5%
• 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
• 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

Qualifications

Must Haves

• You have experience working with software mobile applications
• You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971
• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model
• Your Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Your proficiency to interpret software design and code to verify implementation of requirements
• You have Software development and/or Software test experience
• Your ability to understand complex tasks and goals. Drive projects to completion with limited supervision
• Your ability to communicate and present to all levels of management
• 0-5%
• 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

Nice to Haves

• 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 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.
• Remote work arrangement.