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 we're 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 we've 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. We've already changed millions of lives and we're 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. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've 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:

The Sr. Director of Software Design Quality Engineering is responsible for all aspects of Software Quality Engineering, including managing and mentoring Quality Engineering staff globally. You’ll partner closely and collaboratively to drive the development, test and release of product software and firmware as well as software infrastructure, while ensuring the development process is compliant with all US and International development standards.

Where you come in:

• Manages the Software Quality Assurance Team globally. Defines priorities and delegates responsibilities.

• Leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.

• Promote cross-functional understanding and adherence to quality standards and regulatory requirements.

• Responsible for establishing and reporting on key software development metrics.

• Summarize and report quality findings to executive management during the Quality Management Review, to project/program managers, and the development team as needed. 

• Provides coaching and guidance on defining world class project plans, requirements, design, and test cases.

• Deep understanding of software requirements and best practices toward:

  • IEC 62304 compliance

  • Agile development in medical devices

  • Automated testing methodologies

  • FDA General Principles for Software Validation

  • FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

  • FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

  • FDA Guidance for Post-market Management of Cybersecurity in Medical Devices

What makes you successful:

• Work with R&D to ensure development and test processes comply with the latest regulations and identify potential compliance gaps; work with the departments to discuss how to apply best practices to meet regulations.

• With assistance and buy in from departments, update relevant procedures.

• Guide risk management activities to drive collaborative discussions on appropriate mitigation strategies.

• Ensure the team is prepared for regulatory agency audits

• Provide leadership and expertise in the Design/ Phase Review process to ensure compliance to process.

• Coordinates, manages and tracks the team’s efforts, ensuring milestones are met within defined budgets and schedules.

• Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 820, Quality System Regulation

• Expertise or strong working knowledge of Food and Drug Administration 21 CFR PART 11, Electronic Records; Electronic Signatures.

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:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelors degree in a technical discipline with 17+ years of industry experience.
• 13+ years of years of successful leadership experience in relevant industry.

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 [email protected]. 

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 [email protected]. 

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.
 

Salary:

$209,600.00 - $349,300.00