Broad understanding of software validation techniques for medical or other regulated systems, you will develop a strong understanding of the SW architecture, design, and execute the test strategy, perform release activities of Software tests in compliance with regulatory standards.
Bachelor's Degree required with minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Provide software validation activities as part of the Software operations transfer team in the Software COE of Robotic Surgical Technologies.
Lead definition and implementation of different software testing techniques to provide test coverage for the software used in manufacturing and service.
Using software test engineering techniques to maximize validation coverage with optimal effort in both automation and manual testing.
Develop and deliver all SW Validation deliverables for your project to support regulatory submission.
Understand the technical behavior of the system, architecture, and software requirements with an aptitude to identify software defects in all phases of development.
Coordination of dry runs and formal Validation activities as required.
Collaborate with technical engineering teams, develop software tools when needed.
Knowledge of Medical Product verification, IEC-62304, and FDA guidance.
Understanding of creating test protocols for verifying software requirements.
Strong understanding of good documentation practices.
Ability to work with QA to ensure testing meets Quality and Regulatory needs.
Ability to manage, track, and upgrade multiple hardware and software configurations.
Ability to work with Systems, Mechanical, Electrical, and Software engineers when discovering, documenting, and resolving integration issues.
Familiarity with common programming languages such as C++, C#, and Python.
Experience using a tool or repository for managing test cases (GIT Stash, JIRA).