SDET

• Manage the software testing team and ensure Software verification is conducted in accordance with the FDA standards to deliver high quality software.
• Manage a team of 4-8 software application Manual/SDET test engineers.
• Manage Design Control and Software Test initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices.
• Responsible for the generation, review and approval of design control documentation with primary focus on software test deliverables.
• Collaborate with Project Management to support and optimize the schedules.
• Support software development teams on the validation of software tools.
• Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification and validation of requirements.
• Lead the creation of necessary documentation to comply with regulatory requirements and industry best practices.
• Establish and maintain software test programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
• Ensure compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
• Provide guidance and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management, review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
• Apply a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to software test activities in software development.
• Work closely with the software development team to identify improvements.
• Influence the requirements definition and software design to maximize testability.
• Oversee and influence development of test objects to meet needs of protocol.
• Develop and extend protocols and plans as device features evolve.
• Participate in product design reviews.
• Represent software test in the core team meetings.
• Create and execute test plans, test designs and test cases and generate test reports.
• Create and update Trace matrices between requirements and Tests.
• Work with the scrum Master and product owners to prioritize or deprioritize the backlog.
• Keep track of the Testing board and tools inventory for the team.
• Perform other duties as required.

Manager, Software Test Engineering

Senior Software Development in Test Engineer

Senior Software Development Engineer in Test, SDET

Senior Manager, ATE Test Engineer

Senior Software Engineer – Test

ATE Test Development Engineer