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Lead Software Engineer - V&V

Medtronic Cardiac and Vascular
11-14 years
Not Specified

Job Description

Careers that Change Lives
The Lead Software V&V Engineer position, based in Hyderabad, India, is responsible for various software Quality Assurance functions during the development lifecycle of complex electro-mechanical medical devices.
A Day in the Life
The Lead Software Quality Assurance Engineer position, based in Hyderabad, India, is responsible for ensuring that developed software meets and complies with defined or standardized quality specifications throughout the software development life cycle (SDLC) of complex electro-mechanical medical devices.
The individual will be a part of a small but professional Software Quality Assurance team and will work closely with Software development engineers and other cross functional teams
This position is participating in development of test strategies, test plans and test procedures of various software platforms (i.e. embedded, real-time OS, Client-server, web-based, etc.) including validation/qualification of third-party software components and tools.
The individual will report to the Emgineer Manager and be a part of a SWQA project team that may consist of on and offsite resources and will work closely with software developers and other cross functional team members.
Must Have
Job Respobsibilities
  • Plan, Develop and execute software testing (both manual and automated - White/Black Box) for electrosurgical/Stapling medical devices, based on context and risks associated with the project.
  • Participate in some level of basic software design reviews and documentation that establish high level of confident that the software development meets the required quality parameters.Participate in test activities, incident management and tracking - with both on or offsite test resources.
  • Create test reports suitable for submission to regulatory authorities to demonstrate that software is validated, and all requirements are verified.
  • Responsible for ensuring that the software development process follows established procedures, standards and plans. And the risk associated with the software is identified, analyzed and managed appropriately.
  • Participate in other quality assurance functions, including, but not limited to, supporting compliance audits, test automation strategy and development.
  • Active Participation in team meetings, discussions and customer meetings.
  • Involvement in Innovation, technical discussion's, product/process improvements and Kaizans.

Minimum Qualifications & Specialized Knowledge required
  • ME/MTech/BE/BTech in Electronics & Communication Engineering, Computer Science or relevant field.
  • A 11+ years in software quality assurance, V&V or software quality development.
  • Or, some medical device product experience (preferably electro-mechanical medical device) or regulated fields.
  • At least 8 years Working experience in SWQA of ‘Embedded products on ‘System Sofware Testing.
  • Some working experience in a prescriptive software development environment following a well-defined software development process.
  • Understand test automation concept, and scripting languages (e.g. Python, Perl, etc.)
  • Excellent verbal and written communication skills and works well in a tightly coupled team

Nice to Haves
  • Experience with test equipment such as oscilloscopes, serial port analyzers, multi-meters and general lab measurement equipment.
  • Membership in one or more professional societies and/or professional certification (e.g. CSQE, CSTE, etc.).
  • Familiarity with FDA regulations and recommended practices regarding software (21CFR 820.30, IEC 62304:2015, ISO 14971:2012).
  • Understand Requirements Management, configuration management and defect tracking concepts.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives.Help us shape the future. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

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