Software QA Engineer 2

Dexcom, Inc; San Diego (CA); On-site; USD 79,000 - 132,000; Full time

Benefits offered by this job

Benefits program

Job summary

Dexcom is seeking a qualified R&D Quality Assurance Engineer to join the software-focused QA team. The role provides guidance on IEC 62304, 21 CFR 820, ISO 14971 and related worldwide regulations to cross-functional groups and drives continuous improvement of software development and validation practices.

You will support risk assessments, CAPA activities, design history files, SOPs, and verification activities, collaborating with Software Design, Test, Regulatory Affairs, and Project management

Qualifications

• Experience with software mobile applications.
• Medical device experience in FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971.
• Knowledge of SDLC and methodologies such as Agile and Waterfall.
• Experience in Requirements Analysis, Design/Development, Product Integration and Test.
• Ability to interpret software design and code to verify requirements.
• Experience in software development and/or software testing.
• Ability to communicate and present to all management levels.

Responsibilities

• Participate as core team member of the R&D Quality Assurance Engineering team.
• Lead application, compliance, and continuous improvement of policies and procedures for software development and validation.
• Provide guidance on device and software requirements and driving risk management deliverables.
• Support system validations, design verifications and traceability, configuration management, and tool validations.
• Communicate plans, status, and challenges to Dexcom management.
• Perform other duties as assigned.

Skills

Software quality

Regulatory requirements

Communication

Project management

Education

Bachelor’s degree in technical discipline

Tools

Jama

Jira

Kettryx

TestRails

Job description

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:

This functional department provides technical support and guidance to the Software teams to ensure conformance to software development process and applicable safety and quality system regulation and standards such as IEC 62304, ISO 13485, ISO 14971, 21 CFR 820. We are responsible for various aspects of Software Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project management, System Engineering, Clinical and others). This team has a great team culture by supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude.

Where you come in:

You will actively participate as a core team member of the R&D Quality Assurance Engineering team. You will provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to the cross-functional teams. You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams. You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA. You will provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations. You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable). You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables. You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained. You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges. You will assume and perform other duties as assigned.

What makes you successful:

You have experience working with software mobile applications. You Bring Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971. Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model. Your Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test. Your proficiency to interpret software design and code to verify implementation of requirements. You have Software development and/or Software test experience. Your ability to understand complex tasks and goals. Drive projects to completion with limited supervision. Your ability to communicate and present to all levels of management. Nice to have knowledge of Cyber Security. Nice to have ASQ Certified Software Quality Engineer (CSQE) certification or equivalent. Nice to have Jama, Jira, Kettryx, and/or Test Rails experience.

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: 0-5%

Experience and Education Requirements:

Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2 - 5 years related experience or Master's degree and 0-2 years' equivalent experience.

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 [e-mail]. 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 [e-mail].

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.

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Salary:$78,900.00 - $131,500.00#DexcomUS