Software Engineer - Hyderabad - Medtronic
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The Software V & V Engineer will be responsible for various software verification and validation activities during the development lifecycle of complex electro-mechanical medical devices (ventilators).
This candidate shall be responsible for the verification testing of embedded, real-time software, including the development of test plans and procedures. In addition, the position is responsible for ensuring that the software development process is followed and the risk associated with the software is identified and mitigated appropriately. This individual will participate in design reviews and code inspections and will support the development of documentation required for FDA device approval.
The individual will be a part of a small but professional Software / Systems V & V team and will work closely with embedded software Development engineers.
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Software/Systems Verification and Validation of medical devices - embedded, real-time software, including the development of test plans, protocols/procedures and test execution.
Create test reports for submission to regulatory authorities to demonstrate that system/software is validated and all requirements are verified.
Identify system and software risks ensure risks are appropriately mitigated.
Development of test scripts (LUA, Perl, Python, etc,…).with familiarity in using various test frameworks. Familiarity with the programming language (C/C++/C#...)
Participation in formal verification and validation activities.
Participating in design and code reviews, code inspections and will support the development of documentation required for FDA device approval.
Participation in other quality assurance functions, including, but not limited to, process audits, static code analysis, risk/hazard analysis, and test automation development.
Defining of new product (Software), implementing operational profiles, preparing for test, executing test, and guiding the test.
Support the Validation / qualification of third-party software components and tools used for software development and verification/validation
Support Medtronic corporate continuous improvement initiatives.
Provide support for audits.
Communicates resource or product performance issues to functional management in a timely manner.
Prepares oral presentations for various company meetings.
Required: Minimum of four (4) years of experience in software verification and validation of which minimum two (2) years’ experience should preferably be in the medical device or regulated industry.
KNOWLEDGE, SKILL, AND ABILITY:
Embedded System Software Verification & Validation activities in a regulated industry
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
General Principles of Software Validation; Final Guidance for Industry and FDA Staff : Validation of Automated Process Equipment & Quality System Software
Experience in the Verification of embedded, real-time systems.
Knowledge of C/C++/C# and some familiarity with UML.
Knowledge of developing and executing test scripts (Lua, perl, python,…)
Experience working in a structured software development environment following a well-defined software development and test process.
Experience with software and system risk analysis (per ISO 14971) including fault tree analysis, software failure mode and effects analysis (FMEA).
Familiarity with the medical standards IEC 62304, IEC 60601-1:2005 and collateral standards.
Works with team members, cross-functional teams and global teams.
Ability to accurately estimate tasks and track/communicate progress for software verification and validation tasks
Good verbal and written communication skills
Experience with Requirements Management tools, configuration management tools and defect tracking tools.
Knowledge of system engineering and the ability to understand embedded software and programmable logic risk assessment from a system perspective.
Experience with test equipment such as emulators, oscilloscopes, logic analyzers, serial port analyzers, function generators, multimeters and general lab measurement equipment.
Familiarity with FDA regulations and recommended practices regarding software
Bachelors of Engineering Degree (or higher) in Computer Science / Electronics / Electrical / Communication or similar field.