Staff SW QA Engineer

Meet reputed company: Provides technical expertise for software reputed company assurance activities, including risk management activities following ISO 14971. 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 software reputed company. Where you come in: • You will serve as a technical leader and subject matter expert for software reputed company, risk management, software lifecycle compliance activities. • You will reputed company the effective application, compliance, and reputed company improvement of software development and V&V processes, including: Risk Management, Software Design Controls for Class I/II Exempt Applications & Components • You will reputed company reputed company software reputed company initiatives spanning multiple products, programs, and functional organizations. • You will reputed company risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues. • You will support digital transformation initiatives (ALM, SCM, PLM) to reputed company use of electronic systems supporting SDLC as defined per IEC62304. • You will reputed company technical reputed company and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis. • You will review and approve critical reputed company deliverables, including software development lifecycle documentation, risk artifacts, V&V protocols, and design history file content. • You will reputed company organizational improvements reputed company to software reputed company systems, development practices, automation, verification, validation, and compliance processes. • You will evaluate emerging regulations, standards, and industry trends and assess reputed company to existing and reputed company products. • You will collaborate with senior leadership to define reputed company strategies supporting business objectives and product roadmaps, implementing a right-sized QMS applications based on Software Classification per IEC62304. • You will mentor and reputed company technical leadership to software reputed company engineers and cross-functional development teams. • You will influence project, product, and organizational reputed company through expert risk-based reputed company assessments and recommendations. • You will assume and reputed company other duties as assigned. What makes you successful: • You have 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. • You have advanced 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. • You have deep experience with software reputed company engineering across requirements, architecture, design, development, testing, release, and post-market activities. • You have advanced understanding of software risk management principles, methodologies, and regulatory expectations. • You have demonstrated ability to influence organizational direction and reputed company cross-functional initiatives without reputed company authority. • You have strong understanding of software architectures, reputed company technologies, reputed company systems, cybersecurity principles, and data platforms. • You have experience supporting regulatory inspections and reputed company with FDA, reputed company bodies, and reputed company auditors. • You have exceptional written, verbal, and executive-level communication skills. • You have the ability to manage ambiguity, influence senior stakeholders, and reputed company reputed company programs to successful completion. • You have 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 8-12 years reputed company experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 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 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 AI in Hiring Notice: We may use AI supported tools to help reputed company our hiring process more efficient, consistent, and accessible for candidates around the world. reputed company hiring reputed company are made by people. Salary: $116,600.00 - $194,400.00 Apply tot his job Apply To this Job