Principal Software Verification and Validation Engineer

4 weeks ago

Eden Prairie, United States Bracco Medical Technologies Full time
Principal Software Verification and Validation Engineer LinkedIn Twitter Email Message Share
Why Join Bracco Medical Technologies?

At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems.


Position Description

The Principal Software Verification and Validation Engineer position is a key member of the software development team for Bracco Medical Technologies (BMT) and will develop verification and integration test software across the global product portfolio of the "Digital Health" command center and medical devices. As a member of BMT's global R&D software engineering organization participate and consult on activities in all phases of the software development lifecycle, with focus on verification and validation and integration testing of medical devices and connectivity solutions. This role leverages software testing proficiency to translate product requirements into test strategies and document work to ensure compliance within a regulated Product Development Process (PDP) and Quality Management System (QMS).

Primary Duties & Responsibilities:

  • Create and develop solutions to reduce total cost of ownership (TCO) for customers, improve workflow efficiency and gain visibility over business intelligence of enterprise contrast administration and medical devices
  • Lead overall software testing for OEM connectivity and/or medical device
  • Create overall software test strategy and software integration plan
  • Technical leadership of software test engineers to create effective culture of quality
  • Develop test protocols for verification and validation of software capabilities as specified in the requirements
  • Test requirements, architecture, and design for devices, on-premise, cloud-native, or hybrid solutions to meet the customer's needs
  • Collaborates with Software architect, SW Integration Engineer and Systems engineer to ensure software architecture meets specifications, and there is readiness for verification and validation, based on hazards and customer needs
  • Designing, developing, testing, maintaining, and documenting/validating software testing components, applications, scripts, and tools.
  • Participate in all phases of product development as needed such as reviewing requirements, architecture, design, usability, risk assessment, and testing execution.
  • Drive the culture of engineering excellence and commitment to quality
  • Provide input to requirements development
  • Develop automated and semi-automated test software
  • Prepare test reports of testing results, including formal tests and ad-hoc tests, to document coverage of requirements
  • Provide input to project teams on effort estimation and resource requirements
  • Provide input to product verification and validation test plans
  • Collaborate with 3rd party vendors for test strategy for IHE and other providers of Medical Device Interoperability


Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • Bachelor of Science in Computer Engineering, Computer Science, Software Engineering, Electrical Engineering, Computer Systems Engineering, or a related discipline
  • 8+ years of software development and testing experience
  • 5+ years of experience with test scripts
  • Demonstrated experience in a scripting language (e.g. python)
  • Demonstrated problem-solving and leadership skills
  • Proficiency in software development and integration of software components for testing
  • Experience with test automation including GUI, integration, reliability and designing and implementing test automation frameworks
  • Experience with test management, configuration management and risk management
  • Excellent communication skills to collaborate and influence within R&D, Quality and Program Management for effective program execution

Preferred:

  • MS in Computer Engineering, Computer Science, Electrical Engineering, or related discipline
  • 10+ years of software development and testing experience
  • 5+ years of experience with C#
  • 2+ years of python experience
  • Knowledge of QSR, ISO/EN and Quality System Standards
  • Familiarity with DICOM, HL7, IHE, and/or FHIR
  • Experience with the development tools: MS Visual Studio, Jira, git
  • Proficiency in CI/CD Pipeline tools like Jenkins or Azure DevOps
  • Fluency with clinical radiology terminology
  • Medical Device Interoperability experience with HL7, DICOM and PACS, HIS/RIS
  • Proficiency in software development and integration of software components for testing of device-based software, on-prem and extensibility to cloud-hosted apps
  • Demonstrated results in testing for cybersecurity mitigations
  • Experience with developing critical care medical device products
  • Experience in medical device connectivity and drug-delivery systems
  • Demonstrated competency in understanding and testing the functionality of complex systems
  • Demonstrated experience working with a multi-discipline global team
  • Experience analyzing experimental data, ad-hoc data, reliability data, performance data, etc.
  • Develop applicable testing mechanisms for cloud architecture across diverse areas including application development, identity and access management, network and data management

Job Location 7905 Fuller Road, Eden Prairie, Minnesota
Tracking Code 1291-432
ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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