Where you come in
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, 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.
What makes you successful
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.
Your 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.
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.
You have experience with web APIs.
Your ability to communicate and present to all levels of management.
Nice to have Cyber Security experience
Nice to have ASQ Certified Software Quality Engineer (CSQE) certification.
What you'll get
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.
Travel Required
0 - 15%
Experience and Education
Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.
At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.
Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at talentacquisition@dexcom.com.
