Leads Risk Management (ISO 14971) activities. May leads cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.
Primary skills, technologies and knowledge needed include understanding of relational database concepts; Oracle, SQL Server, and DB2; Business Intelligence tool sets; SAP Business Objects and BI Stack including Crystal reports; Tableau; SQL and SQL tuning; general database and report troubleshooting.
Executes test plans and identifies and documents discrepancies found. Reviews test results through demonstrated ability to accurately assess output results against expected results. Resolves discrepancies with technical personnel and retests as required.
A Software Development Engineer in Test [SDET] is a developer with the primary responsibility of effective assurance of product quality through test automation, code inspections, peer reviews, white-box testing and other forms of engineering excellence.
In this role, the selected candidate will provide periodic reports of status and detailed information as necessary to satisfy project management queries; correct errors by making appropriate changes and rechecking the program to ensure the desired results are produced.
The Application Platform Midrange Engineer collaborates in the standardization, optimization and simplification of platform applications. Will assist with the overall quality, performance and efficiency of those applications.
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and Company Policies & Procedures.
In this role, the selected candidate will be responsible for performing all performance development activities for the System Modernization IT portfolio of projects, beginning with the MPSE project including several cross-agency projects with key collaborators.
Responsible for identifying testing requirements by analyzing user stories, create test plan, develop test cases/scenarios, setup supporting test data and execute test cases manually and using automated tools as well.
In this role, the selected candidate will analyze current regression tests and convert to automated tests; provide analysis of ancillary systems and develop automation solutions to meet the needs of business processes.
In this role, you will provide guidance and support for system security by performing complete assessments of the system portfolio, determine priority of systems that need to be accredited per policy, and ensure prompt compliance.