Software QA Engineer 1

Groupe Kardol; Oregon; Hybrid; USD 62,000 - 103,000; Full time

Benefits offered by this job

Comprehensive benefits

Career growth opportunities

Tuition reimbursement

Job summary

Dexcom is seeking a Software Design Assurance Engineer to ensure conformance to software development processes and safety standards. You will interface with cross-functional teams to guide design, validation, and risk management across software activities.

The role emphasizes regulatory compliance, continuous improvement, and collaboration with Software Engineering, Regulatory Affairs, and Cybersecurity to deliver high-quality CGM solutions.

Qualifications

• Medical device experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Familiarity with SDLC and software development methodologies (Agile/Waterfall)
• Experience in software design assurance, risk management, and regulatory compliance systems

Responsibilities

• Act as a core team member of the R&D Quality Assurance Engineering team
• Provide guidance on IEC 62304, 21 CFR 820, and applicable worldwide regulations
• Lead application and continuous improvement of software development and validation policies
• Drive pre-market risk management deliverables like SHA and design FMEA
• Support post-market activities including risk assessments and CAPA
• Review and approve software design control deliverables
• Communicate plans and status to Dexcom leadership

Skills

Medical Device experience

FDA 21 CFR Part 820

IEC 62304

Quality Assurance

SDLC

Education

Bachelor's degree in a technical discipline

Tools

Cloud platforms

Regulatory documentation tools

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:

The Software Design Assurance (Software Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971). This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement, new product development, and defect prevention. This position will interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering, Cybersecurity, and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

*This is not a test role*

Where you come in:

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Strong understanding of, and ability to provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including:
• Drive Pre-market risk management deliverables like SHA, design FMEA and support Cyber security risk management
• Provide guidance to Software Design and test teams, support Software configuration management, tool validations and software integrations.
• Reviews and approves all software design control deliverables
• Support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
• Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities for products and processes
• Responsible for reviewing, authoring, and revising appropriate technical documentation including design history files, standard operating procedures, protocols, reports, etc.
• Assess the impact of change control to ensure no adverse impact on product performance and a state of compliance is maintained.
• Effectively communicates with the broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges.
• Assumes and performs other duties as assigned.

What makes you successful:

• Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test
• Ability to interpret software design and code to verify implementation of requirements
• Software development and/or Software test experience
• Ability to communicate and present to all levels of management.
• Ability to understand complex tasks and goals. Drive projects to completion with limited supervision.
• Experience working with cloud-based systems.

Preferred Requirements:

• ASQ Certified Software Quality Engineer (CSQE)
• Cyber Security experience
• Experience working with Cloud based infrastructure and systems that process, store and distribute large sets of data continuously.

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.

Experience and Education Requirements:

• Typically requires a bachelor's degree in a technical discipline, and a minimum of 0-2 years of related experience.

Travel Required:

• 0-5%

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].

Salary:

$61,900.00 - $103,100.00