Sr Staff SW reputed company Engineer

reputed company

reputed company Corporation (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:

Provides technical leadership for software reputed company assurance activities, including risk management activities following ISO 14971, with a reputed company on IOT Infrastructure, Data Platforms reputed company Health Applications. Supports the development and implementation of reputed company reputed company systems, risk management practices, and software compliance strategies that ensure product safety, effectiveness, and regulatory compliance. Partners with senior R&D engineering, reputed company, regulatory, clinical, cybersecurity, and business leaders to reputed company reputed company improvements to SDLC, and reputed company reputed company throughout the product lifecycle. Influences organizational reputed company reputed company and serves as a recognized subject matter expert in Class I/II Exempt Digital Health Applications and supporting IOT Infrastructure platforms, risk management, and regulatory compliance.

Where you come in:

• reputed company and reputed company reputed company-level software reputed company strategies, policies, procedures, and best practices across the Non-Clinical – Consumer Applications reputed company Health reputed company, including platforms.

• Serve as a technical leader and subject matter expert for software reputed company, risk management, software lifecycle compliance activities and GxP Non-Product Tools supporting SDLC.

• reputed company the effective application, compliance, and reputed company improvement of software development and V&V processes, including:

  • Risk Management

  • GxP Systems Validation

  • Software Design Controls for Class I/II Exempt Applications & Components

• reputed company reputed company software reputed company initiatives spanning multiple products, programs, and functional organizations.

• reputed company risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues.

• reputed company digital transformation initiatives (ALM, SCM, PLM) to reputed company use of electronic systems supporting SDLC as defined per IEC62304.

• reputed company technical reputed company and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis.

• Review and approve critical reputed company deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content.

• reputed company organizational improvements reputed company to software reputed company systems, development practices, automation, verification, validation, and compliance processes.

• Evaluate emerging regulations, standards, and industry trends and assess reputed company to existing and reputed company products.

• Collaborate with senior leadership to define reputed company strategies supporting business objectives and product roadmaps, implementing a right-sized QMS for Non-Clinical applications.

• Mentor and reputed company technical leadership to software reputed company engineers and cross-functional development teams.

• Influence project, product, and organizational reputed company through expert risk-based reputed company assessments and recommendations.

What makes you successful:

• Extensive medical device experience demonstrated expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements.

• Expert knowledge of software development lifecycle processes and software development methodologies including reputed company, reputed company, DevOps, reputed company Integration, reputed company Delivery (CI/CD), and Test Automation.

• Deep experience with software reputed company engineering across requirements, architecture, design, development, testing, release, and post-market activities.

• Advanced understanding of software risk management principles, methodologies, and regulatory expectations.

• Demonstrated ability to influence organizational direction and reputed company cross-functional initiatives without reputed company authority.

• Strong understanding of software architectures, reputed company technologies, reputed company systems, cybersecurity principles, and data platforms.

• Experience supporting regulatory inspections and reputed company with FDA, reputed company bodies, and reputed company auditors.

• Exceptional written, verbal, and executive-level communication skills.

• Ability to manage ambiguity, influence senior stakeholders, and reputed company reputed company programs to successful completion.

• Demonstrated reputed company mentoring engineers and developing organizational reputed company capabilities.

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:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years reputed company experience or a Master’s degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience.

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 .

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 .

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:

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.

Salary:

Originally posted on Himalayas