About DexcomFounded 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.Job DescriptionMeet the team:This functional department provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971). We are responsible for various aspects of Software Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering 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.**This is not a test role**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.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.You have experience with web APIs.Your ability to communicate and present to all levels of management.Nice to have Cyber Security experienceNice 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.Exempt Salary DetailsThe annual base salary range for this role is $87,000 to $145,000. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.Experience and EducationTypically 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.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 ****** 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 ****** 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=trueTo 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 unsolicitedresumes/applications.Salary:$87,000.00 - $145,000.00
