Sr SW Design Quality Engineer
Job Location:
San Diego, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later having pioneered an industry. And were just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized actionable insights aimed at solving important health challenges. To continue what weve started: Improving human health.
We are driven by thousands of ambitious passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening serving with integrity thinking big and being dependable. Weve already changed millions of lives and were ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve come a long way from our small company days our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the Team:
*This is not a test role*
TheSeniorSoftware Design Assurance (SrSoftware Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance tosoftware development process and other applicable safety and quality system regulation and standards (e.g.IEC 62304 ISO 13485 ISO 14971). This role willbe responsible forvarious aspects of Software Design Assurance with a focus on product improvement new product development and defect prevention. This position willinterface withdifferent cross functional groups (Software Engineering Software Test Regulatory Affairs Marketing Project managers Systems Engineering Cybersecurity and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
*This is not a test role*
Where you come in:
Activelyparticipatesas a core team member of the R&D Quality Assurance Engineering team.
Strong understanding of and ability to provide guidance on IECCFR 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:
DrivePre-marketrisk management deliverables like SHA design FMEAand support Cyber security risk management
Provideguidance to Software Design and test teams support Software configuration management toolvalidationsand software integrations.
Reviews and approves all software design control deliverables
Support post market activities related to Software anomalies riskassessmentsand 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 revisingappropriate technicaldocumentation 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 ismaintained.
Effectively communicates with the broad Dexcom team and upper-level management on plans status of tasks projectprogressand challenges.
Assumes and performs other duties as assigned.
What makes you successful:
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.
Preferred Requirements:
ASQ Certified Software Quality Engineer (CSQE)
Cyber Security experience
Experience working with Cloud based infrastructure and systems that processstoreand distribute large sets of data continuously.
Whatyoullget:
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 Bachelors degreein a technical discipline and a minimumof 5-8 years related experience orMasters degree and 2-5 yearsequivalent 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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at
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
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: 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.
Salary:
$95900.00 - $159900.00Required Experience:
Senior IC
About Company
Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.â€
