About the Role
As a Senior Software Test Engineer at Openwater, you will be responsible for planning and executing software testing. You will work closely with software developers to implement your software testing plans and find software defects. You must be a proactive problem solver who can find and implement software testing tools as we move towards high volume manufacturing and FDA submissions. We are looking for an extremely energetic, creative, self-motivated, hands-on engineer to join our team.
Responsibilities and Duties:
Test planning: Transform requirements into a comprehensive test plan
Test execution: Develop and execute software testing strategies: functional black box, white box, GUI, integration, system, and regression tests. Collaborate with developers on unit test driven development.
Defect resolution: analyze and identify critical software bugs, assist developers in the defect resolution process, provide input to reproduce and document software defects
Verification and validation testing: Ensure the system has been effectively verified and validated prior to its release and the design effectively meets requirements.
Test tools: Configure and validate software tools for testing.
Test vendor management: Manage any necessary specialized external testing firms
Software compliance: Work with a cross-functional team of engineers to drive quality assurance and comply with FDA standards on a Class II medical device. Generate IEC 62304 compliant software validation and verification documentation for regulatory submissions.
Qualifications and Skills:
Minimum 4 years of experience in software testing (of devices).
Strong analytical skills, experience uncovering anomalies in robust software.
Experience with software testing in a regulated environment; knowledge of the software development life cycle and quality assurance methodologies
(ability to read and understand unit tests from SW developers).
Knowledge of or ability to support development of automated tests.
Strong problem analysis and solving skills.
Curiosity and willingness to learn new and emerging technologies.
Strong organizational, verbal, and written communication skills.
Self-motivated person who takes initiative in a constantly-changing working environment.
Medical, IEC 62304, and IEC 14971 experience is a plus.
Experience with hardware testing (such as IEC EMC emissions testing) is a plus.
Openwater is an equal opportunity employer. We celebrate and encourage diversity and are committed to creating an inclusive environment for all employees.
About the Company
Openwater is creating a next-generation imaging technology that can enable us to see inside our bodies in great detail. With this advancement comes the promise of new abilities to diagnose and treat disease