Senior Software Integration Engineer

Responsibilities

• Lead software integration for BMT's medical device product development projects in injection systems for cardiovascular and diagnostic imaging, pursuant to internal standard operating procedures and protocols.
• Ensure the software technical solution effectively meets product and system requirements, and software specifications accurately describe the solution in digital health environments. Design, develop, test, maintain, and document/validate software testing components and applications using C#, Visual Studio, GIT, JIRA, .NET, and Python test scripts.
• Lead product development project software efforts, including input to requirements development, test strategy and system integration plans, development of automated and semi-automated test software, preparation and analysis of experimental results and test reports, and feedback to the project team validating test plans.
• Test for PACS, DICOM, HL7 and FHIR. Demonstrate test protocols with statistically valid methods and document coverage of requirements.
• Work on cross-functional teams with Software, System Test, Quality Assurance and Regulatory Affairs to coordinate activities, produce deliverables, review work and address variances.
• Collaborate with Architect and Lead Systems Engineer to ensure software architecture meets specifications, and there is readiness for verification and validation, based on hazards and customer needs. Manage software integration between sub-systems and major components for connectivity and digital health. Integration includes software and hardware in custom hardware-based systems with connectivity to Electronic Medical Record systems.
• Provide Dev Ops support development and testing. Serve on Software Development team to ensure testability of requirements and provide input to development engineers to solidify robust design and code.
• Participate in technical activities in all phases of the software development lifecycle, with focus on systems integration for concept to productization for development of medical devices.
• Lead the definition of requirements and evaluation criteria for third-party engineering service vendors which provide surge capacity resources for BMT.
• Stay current on changes in engineering standards (IEC, ANSI, etc.) and provide interpretation of standards for verification and validation planning.

Minimum

• Master’s in Computational Biology, Computer Engineering or Computer Science and five years of experience as a software developer or related occupation in software development.
• Must possess five years of experience:
• Software development or verification and validation in medical devices
• SDLC (Software Development Lifecycle) experience for Concept to Productization and Market Launch
• Must possess four years of experience:

• Programming skills in C#, Visual Studio, GIT, JIRA, and .NET environment
• Working on cross-functional teams with Software, System Test, Quality Assurance and Regulatory Affairs to coordinate activities, produce deliverables, review work and address variances.
• Must possess two years of experience with:

• Testing in specialized environment of digital health
• Implementation of standards related to Class II medical devices and applicable regulations
• Lead overall software effort on product development project including:
• Input to requirements developments
• Test Strategy and Systems Integration plan
• Developing automated and semi-automated test software
• Preparing, analyzing experimental results and preparing test reports
• Demonstrating test protocols with statistically valid methods and documenting coverage of requirements
• Providing input to project teams on task durations and resource requirements
• Validation test plans

• Must possess one year of experience with:

• Injection systems for cardiovascular and diagnostic imaging
• Proficiency in testing for PACS, DICOM, HL7 and FHIR
• Developing Python test scripts
• Integration of complex models of software and firmware in custom hardware-based systems with connectivity to EMR (Electronic Medical Record) systems