Note: The job is a remote job and is open to candidates in USA. Dexcom is a global medical technology company developing continuous glucose monitoring and biosensing solutions. The Software Design QA Engineer 2 provides technical guidance to software teams to ensure compliance with software development, safety, and quality regulations, while supporting risk management, design assurance, documentation, and continuous improvement across product development and post-market activities.
Responsibilities
- You will actively participates as a core team member of the R&D Quality Assurance Engineering team
- You have an understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
- 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, including:
- You will drive pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management
- You will provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations
- You will review and approve all software design control deliverables
- You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
- You will lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes
- You will responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc
- You will assess the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained
- You will effectively communicate with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges
Skills
- You have an understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
- You have Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
- You have knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc
- You have Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
- You have the ability to interpret software design and code to verify implementation of requirements
- You have Software development and/or Software test experience
- You have the ability to communicate and present to all levels of management
- You have the ability to understand complex tasks and goals. Drive projects to completion with limited supervision
- You have experience working with cloud-based systems
- * 5-15%
- * Typically requires a Bachelor's degree in a technical discipline and 2–5 years of related experience, or a Master's degree and 0–2 years of equivalent industry experience
- Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
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 workplace with a home office; if you reside within commuting distance of a Dexcom site, a hybrid working environment may be available through the Flex workplace option.
Company Overview
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