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 functional department provides technical support and guidance to product teams to ensure conformance to product 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 Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Product HW/SW Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering and others). We work closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Perform risk assessments and evaluations for products that conform to established standards and agency regulations.Where you come in: <ul><li>You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA.</li><li>You will be analyzing risk and apply effective risk management and/or risk-based quality guidance controlling risk, verifying risk controls, and maintaining risk management throughout the product lifecycle.</li><li>Coordinate with team members to update Risk Management File and other risk artifact.</li><li>Perform risk evaluations associated with post market data, give guidance to risk evaluations for product development.</li><li>Support in finding quality improvements related to Risk Management processes.</li><li>You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)</li></ul>What makes you successful: <ul><li>You have experience working with medical device software. </li><li>You bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971.</li><li>You have experience with EU MDR.</li><li>Your ability to understand complex tasks and goals. Drive projects to completion with limited supervision.</li><li>Your ability to communicate and present to all levels of management.</li><li>Nice to have Cyber Security experience</li><li>Nice to have ASQ Certified Software Quality Engineer (CSQE) certification.</li></ul>What youll get: <ul><li>A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.</li><li>A full and comprehensive benefits program.</li><li>Growth opportunities on a global scale.</li><li>Access to career development through in-house learning programs and/or qualified tuition reimbursement.</li><li>An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.</li></ul>What you’ll get: <ul><li>A front row seat to life changing CGM technology. <a href="https://www.dexcom.com/warriors" target="_blank">Learn about our brave #dexcomwarriors community</a>.</li><li>A full and comprehensive benefits program.</li><li>Growth opportunities on a global scale.</li><li>Access to career development through in-house learning programs and/or qualified tuition reimbursement.</li><li>An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.</li></ul>Travel Required: <ul><li>5-15%</li></ul>Experience and Education Requirements:<ul><li>Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2 – 5 years related experience or Masters degree and 0 – 2 years equivalent experience.</li></ul>Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.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. 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:  <a href="https://protect-us.mimecast.com/s/fufTCyPOPqFWlgBzhMXJ2t?domain=health1.meritain.com" target="_blank">https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&amp;brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&amp;lock=true</a>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:$75,200.00 - $125,300.00