Job: Software Verification & Validation Engineer
Position Type: Full-time – Permanent
Location: Bangalore, Karnataka (IN)
Minimum 4 years working in Software Verification and Validation, Quality Assurance Engineering in a Medical Device company or other similarly regulated industry.
Roles and Responsibilities
- The successful candidate will be responsible for the execution of Acceptance Test Protocols for medical device software solutions: mobile Apps (iOS and Android), and extended capabilities with App-to-App, App-to-Cloud, and Cloud-to-Cloud integrations. To be considered for this role, you must have a Bachelor’s degree or equivalent in Electrical Engineering or Computer Science, or equivalent technical discipline with a minimum of six year’s work experience in software verification in waterfall and agile DLC (4 years w/Masters).
- Responsible for quality preparation and execution of Acceptance Tests Protocols (ATP’s) for new and sustaining product development programs. Understands conceptually, requirements coverage and traceability and is familiar with specifications in various form factors such as Use Cases, and User Interface Specifications.
- Prepare Acceptance Test Reports documenting the System Under Test (SUT), and ATP pass/fail results per SOPs.
- Contribute to overall product quality by effective and efficient software defect identification. Perform retest to ensure defects are fixed properly with no degrades elsewhere in the system.
- Own all aspects from a QA perspective including but not limited to manual testing, functional testing, and regression testing.
- Participate in the development of medical device software in a MasterControl test environment; through stages of design inputs to design outputs and transfer.
- Responsible for designing, developing and maintaining test cases and strategies to meet release deliverables, project testing requirements and other quality and regulatory considerations.
- Work closely with Software Developers and Project Managers to understand how product changes affect maintenance of test cases, QMS, and other design variables.
- Maintain well-organized records of test results.
- Generate test data as needed.
- Communicate test progress, test results, and other relevant information to management and project stakeholders.
- General issue tracking and working with development and support staff to ensure that that issues are dealt with in a timely and professional manner.
- Troubleshoot defects and manage defect tracking and resolution processes so that a consistent, documented process is used and followed.
- Contribute to written procedures/practices such as SOPs or Validation Reports and assist in maintaining compliance documentation as needed.
- Bachelor of Science or equivalent in Electrical Engineering or Computer Science, or equivalent technical discipline.
- Minimum of six years’ work experience in software verification in waterfall and agile DLC (4 years w/Masters).
- Current knowledge of FDA and EU medical device quality system requirements (ISO 13485, 21 CFR 820)
- Experienced in software verification & validation of FDA Class II medical devices. Experience using Requirements Management and Defect Tracking Systems:
- Experience testing both iOS and Android based mobile Apps especially those related to Medical and Healthcare.
- Review product requirements documents and create test cases to ensure code generated by the engineering team conforms to the specified requirements.
- Perform and design testing protocols to ensure that the product is fully tested.
- Perform system test and integration testing on the product.
- Utilize a bug tracking system to file and review bugs, and to verify bug fixes.
- Work with various teams in the organization to ensure appropriate project requirements are met.
- Participate in a Quality Assurance team that is responsible for ensuring all quality standards for the product are met.
- Ability to carry out all policies and procedures as established by the team, department or company at large.
- Demonstrated understanding of problem solving and quality improvement techniques.
- Capacity to respond to common inquiries or complaints from across business departments.
- Ability to write verification tests and validation reports.
- Works well in a team-oriented environment as well as on your own.
- Strong organizational and communication skills — effectively communicate with technical and non-technical staff.
- Basic Quality Management System concept knowledge.
About AgEye Technologies
AgEye Technologies is pioneering the use of computer machine vision, deep learning neural networks and IoT-connected devices to create the next generation of intelligent agriculture solutions. We’re a dedicated team of agriculturists and technologists that have a passion for digital horticulture, artificial intelligence and creating a sustainable food supply for the growing global population. Our mission is to develop technology that will help produce better tasting, healthier crops that generate more profit, while also giving better visibility into large scale indoor farming operations. We provide our employees with a rich, creative and collaborative environment to further their skills, interests and experience in their particular field, and possibly other fields in which they display interest.
We are an equal opportunity employer. We welcome people of different backgrounds, experiences, abilities and perspectives. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.