FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Tech Stack
Tools & technologiesCloudCyber SecuritySDLC
About the role
Key responsibilities & impact- Actively participates as a core team member of the R&D Quality Assurance Engineering team.
- Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
- Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
- Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management
- Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations.
- Reviews and approves all software design control deliverables
- Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
- Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes
- Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
- Assesses the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
- Effectively communicates with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges.
Requirements
What you’ll need- Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
- Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
- Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
- Ability to interpret software design and code to verify implementation of requirements
- Software development and/or Software test experience
- Ability to communicate and present to all levels of management.
- Ability to understand complex tasks and goals.
- Drive projects to completion with limited supervision.
- Experience working with cloud-based systems.
- ASQ Certified Software Quality Engineer (CSQE) (preferred)
- Cyber Security experience (preferred)
- Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously (preferred).
Benefits
Comp & perks- 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
IEC 6230421 CFR 820ISO 13485SDLC processesAgile Software DevelopmentWaterfall ModelRequirements AnalysisSoftware DevelopmentSoftware TestingCyber Security
Soft Skills
communicationpresentationproject managementproblem-solvingleadershipguidancecollaborationadaptabilityattention to detailcritical thinking
Certifications
ASQ Certified Software Quality Engineer (CSQE)