The Lead Engineer, Health Software Systems Test, will design and develop test standards, testing protocols, and documentation and will aid in the quality of software system features for a medical wearable technology. This role will interact with customers/partners and their software testing teams, and will work closely with health developers and engineers to ensure the delivery of a platform that will be used in the hospital operating room, clinic, and home setting. The candidate will also work in collaboration with other engineering disciplines, regulatory, quality, systems design, product management, and program management to deliver products according to the product development roadmap. The candidate will need software testing principles in requirements development, regression testing, exploratory testing, issue management, automated testing, and quality assurance.
- Provide leadership for software system testing and ensure the quality of software created for, and in support of, health and wellness use cases.
- Generate system level software testing strategy and planning to align with project deliverables to set and meet important project deadlines.
- Responsible for tests that cover software system functionality, usability, local and remote performance, cloud load testing, security, and reliability.
- Create, execute, and document software system test protocols (manual and automated), test cases, and test reports while guiding less experienced colleagues on techniques and industry quality standards. This includes exploratory, regression analysis and testing, and the generation of defect reports.
- Collaborate with quality assurance on continuously defining, maintaining, and optimizing internal procedures for software testing, defect management, software risk analysis, and release management processes. Work closely with internal software and quality teams on process improvements.
- Contribute to understanding, modifying, and collaborating on the creation of system and software requirements and ensuring proper acceptance criteria for test creation.
- Collaborate on the optimization and maintenance of software release management tools and processes, and work with software developers on optimizing release and testing cadence.
- Coordinate with the software systems team to set, maintain, and work on existing and new internal tools and processes for software test management, issue/defect management, and field complaint management.
- Collaborate on the creation, execution, documentation of software system verification and validation in conjunction with V&V testing lead and platform teams.
- 7+ years experience working in system level software testing for a medical device or SaMD in a medical regulated environment (FDA/EU).
- Excellent written and verbal communication skills with experience in project leadership for software system testing.
- Understanding of software system testing methods as per IEC 62304: Medical device software - Software life cycle process.
- Experience in testing Graphical User Interfaces, Algorithms, 3D/2D model visualizations, and expected system behavior and performance.
- Knowledge of C, C++, and/or Python is strongly preferred.
- Knowledge of Jira, Rally, or other task and issue tracking software is strongly preferred.
- Knowledge of git, svn, gerrit, and/or testrail is strongly preferred.
- Knowledge of cloud based technologies and load testing is preferred. (PaaS, SaaS, Storage)
- Understanding of software test architecture and software tools for web and mobile software applications is preferred.
BS in Software/Computer/Biomedical Engineering or another related engineering field; MS preferred