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Sr. Software Engineer – Development and Test


This is a Contract position in Sunnyvale, CA posted July 11, 2019.

Position Description:Sr.

Software Engineer – Development and Test.

Covidien LP (a Medtronic company).

Sunnyvale, CA.

Develop and test Windows based applications which acquire data from patient data recorders and provide display and analysis tools for the physicians.

Utilize C++, VB, Access and SQL to develop utilities and scripts for use in development, testing and test automation.

Review clinical research publications and extracts trends relevant for product development.

Understand human anatomy and physiology; collaborates with clinical researchers to define clinical requirements and diagnostic algorithms.

Develop algorithms to analyze biological signals and calculate diagnostic parameters reflecting recent clinical publications Apply various testing methodologies such as black box, white box, functional, and integration to verify and validate medical device software applications.

Diagnose system level defects (inclusive of hardware and software components), perform root cause analysis of issues and debug defects as needed.

Utilize DevOps skills to support team with Windows installer development, OS image creation and maintaining up SW development & test infrastructure.

Coordinate product development activities within software group from projects, processes and resources perspectives.

Interface with other departments (hardware R&D, RA, QA, Marketing) to facilitate product development and maintenance.

Coordinate all aspects of the software development life cycle process including elicit requirements, designing a solution, implement, test and support.

Participate in Quality audits and assists in regulatory submissions to include Letter to File or 510(k).

Navigate the complexities associated with Medical device software testing required including many government and industry requirements to include 21 CFR 820, IEC 62304, IEC 60601, ISO 13485 and 14971.

Use various quality procedures and toolsBasic Qualifications:Master’s Degree in Biomedical Engineering or related engineering degree and 2 years of experience in software development and testing.

Also requires a minimum of 2 years of experience with each of the following: C++, VB Access and SQL; Reviewing clinical research publications to determine trends for clinical product development; Working with clinical researchers to define product requirements; Medical device software testing and processes; UI ( User Interface) and API (Application Programming Interface) test automation tools; Software DevOps(Software Development Operations) skills, including Windows installer development, OS image creation, maintaining SW development infrastructure; Software project planning; All phases of software development life cycle; Medical regulations (FDA, MEDDEV, SFDA, ISO) to include 21 CFR 820, IEC 62304, IEC 60601, ISO 13485 and 14971