Software QA Engineer 1

Overview

Core team member of the R&D Quality Assurance Engineering team, providing guidance on software development process, regulatory compliance and validation to cross-functional software teams for a medical device company.

What you'll do

• Provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide to cross-functional teams.
• Lead the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams.
• Provide technical guidance on equipment, software, product and process requirements and drive risk management deliverables such as SHA, design FMEA and process FMEA.
• Provide guidance to Software Design and Test teams on system validations, software design verification and traceability, software configuration management, tool validations and software integrations.
• Support post-market activities related to software anomalies, risk assessments and CAPA activities (if applicable).
• Review, author, revise and approve technical documentation including design history file, standard operating procedures, protocols, reports and software design control deliverables.
• Assess impact of change control to ensure no adverse impact to product performance and that a state of compliance is maintained.
• Communicate effectively with the broader Dexcom team and upper-level management on plans, task status, project progress and challenges.
• Assume and perform other duties as assigned.

What you'll need

• Experience working with software mobile applications.
• Medical device experience in compliance with FDA 21 CFR Part 820, IEC 62304 and ISO 13485.
• Knowledge and experience with SDLC processes and software development methodologies such as Agile Software Development and Waterfall Model.
• Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test.
• Proficiency to interpret software design and code to verify implementation of requirements.
• Software development and/or software test experience.
• Ability to understand complex tasks and goals and drive projects to completion with limited supervision.
• Experience with web APIs.
• Ability to communicate and present to all levels of management.
• Typically requires a Bachelor's degree in a technical discipline and a minimum of 2-5 years related experience, or a Master's degree and 0-2 years' equivalent experience.

Nice to have

• Cyber Security experience.
• ASQ Certified Software Quality Engineer (CSQE) certification.

Details

• Location: Bengaluru, India.
• Travel required: 0-15%.