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Sr Software Quality Engineer

📁
Engineering
📅
20000GLK Requisition #

Careers That Change Lives

In this exciting role as a Sr. Software Quality Engineer you will have responsibility for software quality and software safety risk management for a leading-edge, minimally invasive surgical  laser ablation system.

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

Neuromodulation delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
  • Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Defines appropriate measures to ensure product quality.
  • Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
  • Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
  • Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
  • Reviews include applicable specifications, materials, tools, techniques, and methodologies.
  • Provides or directs verification and validation of software system requirements, traceability, and testability.
  • Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
  • Engage cross-functionally to implement improvements to the software development life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques.
  • Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.
  • Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures.
  • Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
  • Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen.
  • Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
  • All activities must be performed in compliance with the Quality System.
  • Travel requirement: less than 25%      

Must Have: Minimum Requirements  

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

Nice to Have

  • Experience in a Regulated environment, preferably Medical Devices
  • Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle.
  • Working knowledge in one or more of the following areas: C/C++, Linux/Unix, Python, automated testing frameworks
  • Experience in effectively applying software quality tools for static code analysis, code coverage, code quality, etc.
About Medtronic
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.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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