Software QA Engineer 1

Dexcom Inc.; Bengaluru; On-site; INR 900,000 - 1,400,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development programs

Innovative workplace culture

Job summary

Dexcom Inc. seeks an experienced Software Quality Assurance Engineer to support R&D. You’ll drive regulatory compliance, software risk management, and validation activities across global teams. Knowledge of IEC 62304, FDA 21 CFR Part 820 and ISO 13485 is essential.

You will oversee documentation, design control, and post-market activities, ensuring traceability and quality throughout software development and testing processes.

Qualifications

• Bachelor's degree in a technical discipline with 2–5 years of related experience, or a Master’s with 0–2 years experience.
• Experience with medical device software regulatory requirements (FDA 21 CFR Part 820).
• Familiarity with IEC 62304, ISO 13485 and SDLC processes.
• Proficiency in software design, development, integration, and testing.
• Ability to interpret software design and code to verify requirements.

Responsibilities

• Review, author, revise, and approve design history files, SOPs, protocols and software design control deliverables.
• Guide cross-functional teams on regulatory and quality requirements worldwide.
• Lead risk management activities and document traceability across software projects.
• Support system validations, software design verification, and tool validations.
• Assist post-market activities related to software anomalies and CAPA as applicable.

Skills

Software mobile apps

FDA 21 CFR Part 820

IEC 62304

ISO 13485

SDLC

Agile

Waterfall

Software quality

Requirements analysis

Design/Development

Product integration & test

Software testing

Web APIs

Cyber security

CSQE (nice to have)

Education

Bachelor's in technical discipline

2–5 years related experience

Master's degree (0–2 years equiv)

Tools

Web APIs

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 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). 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 managers, Systems Engineering and others). This team has a great team culture supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude. This is not a test role

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, 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.
• Your knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• You have 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.
• You have experience with web APIs.
• Your ability to communicate and present to all levels of management.
• Nice to have Cyber Security experience
• Nice to have ASQ Certified Software Quality Engineer (CSQE) certification.

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 - 15%

Experience and Education

• 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.

AI in Hiring Notice:

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].