Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.
Meet the team:
This functional department provides technical support and guidance to Firmware/Software teams to ensure conformance to the software development lifecycle (SDLC) process and other applicable safety and quality system regulations and standards (e.g., FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971). We are responsible for various aspects of Software Design Assurance with focus on new product development, product improvement/sustaining, and defect prevention. We interface with various cross-functional groups such as R&D (including Software/Algorithm/Electrical/Mechanical/System/Test Engineering), Regulatory Affairs, Project/Program Management, Operations/Manufacturing, Clinical, Marketing, and others. This team has a great team culture supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude.
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 FDA 21 CFR Part 820, IEC 62304, ISO 13485, 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 V&V across R&D/Engineering.
You will provide technical guidance with respect to software (product and non-product), process requirements and driving risk management deliverables (e.g., Software Level of Concern and Safety Class, System Hazard Analysis, dFMEA, etc.).
You will provide guidance to R&D/Engineering for software and system testing (V&V) and traceability, software configuration management, tool validation and software integration.
You will support post-market activities related to software anomalies, risk assessments and CAPA activities (as applicable).
You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including Design History File (DHF), Risk Management File (RMF), Standard Operating Procedures (SOP), and 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.
*This is not a test role*
What makes you successful:
You are detail-oriented, a strong collaborator, and passionate about quality and continuous improvement.
You have Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971.
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 are proficient in interpreting software design and code to verify implementation of requirements.
You have experience in Firmware/Software development and/or Firmware/Software testing.
You can understand complex tasks and goals. Drive projects to completion with limited supervision.
You can communicate and present to all levels of management.
Nice to have experience with Algorithms and Clinical Studies.
Nice to have Cybersecurity experience.
Nice to have experience with Software Configuration Management (SCM) tools and practices.
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.
Experience and Education Requirements:
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.
View the OFCCP's Pay Transparency Non Discrimination Provision at this link.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true
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.
