Participates on project teams to develop clear specifications, feasibility plans and reports and system integration tests.
Ensures adequate translation of system requirements to module requirements.
Participates in requirements analysis and designing of test strategies and test procedures/scripts to evaluate the behavior of the system/software/firmware as compared to the specified requirements.
Plans and executes system integration and system/software verification activities.
Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.
Prepares standard reports/documentation to communicate status and results.
Creates, reviews, and approves required FDA/QSR equipment documents including specifications and qualifications.
Supports system risk management activities, Use/Design FMEA’s, risk/hazard analysis.
Minimum Qualifications:
B.E./B.Tech in ECI, Biomedical preferrable.
8-11 Years of experience to be considered.
Must have:
Manual Tester, Engineer should have automation with Python knowledge.
Testing experience in medical device (Implant Experience) is required.