Software Developer

Job Description

• Performs software verification and validation activities as a part of the overall software engineering process for medical diagnostics instruments.
• Typical products include blood gas analyzers and urine chemistry analyzers.
• Verify through testing or inspection that the product functionality meets the software requirements and design.
• Design, develop, and execute software tests to verify design meets documented requirements.
• Plan and implement configuration of physical setup of equipment.
• Create/track software defects in the defect tracking database and verify closure of defects.
• Report passed and failed requirements to the test team lead, the project team, and the department manager.
• Communicate task status to the test team lead and manager.
• Interact with other test and development personnel on a project.
• Manage own priorities, with support from the Test Lead.
• Multitask effectively on and across projects.
• Communicate effectively one on one as well as in groups.
• Ability to work in the U.S. and travel to domestic and international locations.

• Must have knowledge of how software verification / validation activities integrated within a software development process.
• The software test engineer required skills include:
• Experience in writing automated test scripts for embedded software systems applications
• Black-box, performance, stress and load testing, as required by the project
• Performing manual testing, and possibly automated testing, of product features
• Providing documented evidence of test execution
• Participating in risk management (project, technical, and hazard) activities
• Proficiency in Microsoft Word and Excel
• Ability to comprehend software design documents
• Ability to peer-review software requirements and design documents.
• Ability to create manual tests for semi-complex software modules from requirement and design documents
• Ability to create Requirements Trace documentation for tools used to verification and validation and for semi-complex software
• Ability to work effectively both alone and as part of a team
• Possesses strong writing, presentation, and general communication skills
• Ability to handle a variety of tasks and juggle multiple assignments
• Ability to create Test Plans and Test Reports for tools used in support of verification and validation

• FDA Design Control regulations and associated standards and guidances
• Microsoft Team Foundation Server scripting, particularly in the area of build automation
• Automated testing tools, such as Microsoft Coded UI
• Experience with testing medical devices
• Experience on an Agile/Scrum team
• ASTQB Certification (or the equivalent)
• Database fundamentals
• Communication protocols
• Network monitoring
• Computer system performance monitoring
• Various programming languages, such as C#, C , C or Visual Basic
• Communication protocols, such as LIS 3, HL7
• Chemistry
• Calculated Parameters for reported analytes
• Statistical Data Analysis
• Project management experience
• Strong organizational and administrative skills

• BS/MS in Computer Science or Engineering, or 2-4 years of successful experience in a related field and the successful demonstration of Key Responsibilities, Knowledge and skills as presented above.
• An appropriate advanced degree may be substituted for experience, where applicable.