Note: The job is a remote job and is open to candidates in USA. Dexcom is a global medical technology company focused on continuous glucose monitoring and improving human health. The Software QA Engineer 2 will support software quality assurance for medical device products by guiding regulatory compliance, software validation, risk management, design controls, documentation, and post-market activities across cross-functional teams.
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
- 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
- 0-5%
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.
Company Overview
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