Software Quality Assurance

When you’re part of the team at ITJuana, you’ll do meaningful work. ITJuana’s mission is to enable our customers to create technology centers of excellence in Tijuana Mexico.  ITJuana is helping to create a thriving innovation economy in the Tijuana/San Diego region.

The position will be working with one of our customers, Dexcom Inc. and will be based in Tijuana (this is an onsite position).

About the Software Center of Excellence in Tijuana, Mexico:

Dexcom,Inc., a San Diego based company, founded in 1999, provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes.  Due to the profound impact of this technology, Dexcom is expanding its digital capabilities in Tijuana.  

From responsive single page web apps to sophisticated container-based orchestration, compelling native iOS/Android mobile experiences to timely data-driven insights, the Tijuana SW Center of Excellence offers a range of exciting challenges for professional Software Engineers.  Bring your creative and analytical skills to a team where you’ll be inspired, empowered, and rewarded for life by creating products that impact hundreds of thousands of families every day.

Location/Division Specific Information

Tijuana Mexico/ Software Division

How will you make an impact?

This position is responsible for ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices

What will you do?

• Participate in the effective application, compliance, and continuous improvement of practices related to software development and validation across software teams, including:

1. Risk Management
2. Systems Validation
3. Traceability
4. Software Design

• Assess products and systems to identify defects, abnormalities, and design flaws.
• Support Design Control and Software Development initiatives FDA medical devices, mobile applications, and cloud-based systems. 
• Participate in cybersecurity and other risk management processes (DFMEA, PFMEA, SHA).
• Ensure software development documentation complies with regulatory requirements and industry best practices.
• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
• Applies a good working knowledge of Software Development Life Cycle, Design Controls, and other regulatory requirements and agencies as it relates to Design Quality Assurance activities in software development. 

This role will interface with other Dexcom departments as well as other external parties on issues related to product development and launched product support. The ability to effectively communicate software and design and development regulations, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.

How will you get here?

Education

Typically requires a bachelor’s degree in an engineering/scientific/Computer systems or quality management or, and a minimum of 3 years related experience 

Experience

• Understanding of QMS or best engineering practices in Software and Testing
• Medical Device industry experience is a plus
• Experience with risk assessment and risk-based design
• Test automation experience
• Agile and scrum hands-on experience

Knowledge, Skills, Abilities

• ASQ Certified Software Quality Engineer (CSQE)
• Learning agility
• Ownership of your work
• Collaboration/relationship building
• Effective verbal and written communication skills
• Experience with Agile Software Development principles preferred.
• Ability to prioritize and manage key deliverables in a dynamic, fast-paced high energy environment. Must be able to handle multiple responsibilities concurrently.
• Strong analytical and problem-solving skills.