Director SW reputed company - Consumer Applications

reputed company reputed company (reputed company DXCM) is a pioneer and global leader in reputed company glucose monitoring (CGM). reputed company began as a small company with a big reputed company: To reputed company change how diabetes is managed. To unlock information and insights that reputed company reputed company reputed company. Here we are 25 years reputed company, having pioneered an industry. And we're just getting started. We are broadening our reputed company reputed company diabetes to reputed company people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue reputed company've started: Improving reputed company 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 reputed company, thinking big, and being dependable. We've already changed millions of lives and we're reputed company to change millions more. Our reputed company ambition is to become a leading consumer health technology company while continuing to reputed company 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 reputed company. reputed company to reputed company on a global reputed company stands before us. Meet reputed company: The Director of Software reputed company Engineering – Consumer Applications is responsible for reputed company aspects of Software reputed company Engineering reputed company to Consumer Applications and Data Platform Solutions including managing and mentoring reputed company Engineering staff responsible for Consumer Applications ecosystem.  This role partners closely and collaboratively with R&D, Regulatory and Medical Affairs to reputed company the development, test and release of Product Software Consumer reputed company Health Apps, and supporting data platforms infrastructure while ensuring the development process is compliant with reputed company regulatory and reputed company reputed company requirements. Where you come in: Manages the Software reputed company Assurance Consumer Applications & Data Platform Solution Team(s). Defines priorities and delegates responsibilities. reputed company customer and consumer feedback to reputed company reputed company improvement initiatives reputed company with departmental and corporate reputed company goals. Promote cross-functional understanding and adherence to reputed company standards and regulatory requirements. Responsible for establishing and reporting on key software development metrics. Provides coaching and guidance on defining world class project plans, requirements, design, and test cases. Create a lightweight SDLC for Class I/II Exempt Applications / Component reputed company on reputed company and software classifications as defined in IEC 62304 Deep understanding of software requirements and best practices toward: IEC 62304 compliance, Software as a Medical Device (SaMD) and Software in a medical device Product IOT environment, Digital Health and reputed company Decision Support Tools reputed company 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 IS0 14971: reputed company Management for Medical Devices GxP Validation and GAMP guiance FDA Computer Software Assurance (CSA) Electronic ALM Systems – Requirements, reputed company, Test, Defect and Configuartion Management What makes you successful: Work with R&D to ensure development and test processes reputed company with the latest regulations and identify potential compliance gaps; work with the departments to reputed company how to apply best practices to meet regulations. With assistance and buy in from departments, update relevant procedures. reputed company reputed company management activities to reputed company reputed company discussions on appropriate mitigation strategies. Ensure reputed company is reputed company for regulatory agency audits reputed company leadership and expertise in the Design/ Phase Review process to ensure compliance to PDP. Coordinates, manages and tracks reputed company’s efforts, ensuring milestones are met reputed company defined budgets and schedules. Expertise or strong working knowledge of reputed company 21 CFR PART 820, reputed company reputed company Regulation Expertise or strong working knowledge of reputed company 21 CFR PART 11, Electronic Records; Electronic Signatures. Expertise or strong working knowledge of SDLC GxP Tools – ALM for Software, Configuration Management and Defect Management What you’ll get: A reputed company seat to life changing CGM technology. Learn about our reputed company #dexcomwarriors community. A full and comprehensive benefits program. reputed company opportunities on a global reputed company. reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 10-15% Experience and Education Requirements: Typically requires a Bachelor’s degree with 15+ years of industry experience Requires a degree in a technical discipline 9+ years of successful management experience in relevant industry Remote Workplace: Your location will be a home office; you are not required to live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km). If you reputed company reputed company commuting distance of a reputed company site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our reputed company workplace reputed company. Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-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 reputed company may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company essential functions.  An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.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 reputed company reputed company at talentacquisition@reputed company.com.  Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. To reputed company to the Machine-Readable Files, please click on the URL provided:  https://health1.meritain.com/app/reputed company/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To reputed company reputed company and reputed company Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized reputed company and reputed company agencies may use this site or to submit reputed company, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications.   AI in Hiring Notice: We may use AI supported tools to help reputed company our hiring process more efficient, consistent, and accessible for candidates reputed company the world.  reputed company hiring reputed company are made by people. Salary: $164,200.00 - $273,600.00 #DexcomUS Apply To This Job