Careers That Change Lives The Software Quality Engineer I will drive high quality software through software design assurance engineering support to new product development and sustaining activities within the Medtronic Neuromodulation Pre-Market Quality organization. This includes evaluating and driving improvements in design, reliability and safety to ensure these are proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. This role may also have the opportunity to flex into the released-product space to support product performance monitoring, issue management, and continuation engineering support. Neuromodulation therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients. A Day in the Life - 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. - Represent the Pre-Market Quality organization in the development of embedded firmware, application software, and digital health products. - Performs and facilitates risk management, software risk analysis, fault tree analysis, failure trending and failure analysis. - Provide input to design/process development, design controls, test development, and design validation for achieving required levels of product safety and performance. - Develop and implement software quality plans and metrics and create compliant documentation in accordance with US FDA and medical devices software global regulations. 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 0+ years of work experience in Engineering and/or Quality. Nice to Have: Preferred Requirements - Strong understanding of voice of customer, software development, requirements analysis, risk management, software testing software reliability, - Experience working on projects using Agile SW development - Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications - Knowledge of scripting languages and test automation - Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.), 62304 (medical device SW), and 82304 (health care SW) - Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships - Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude - Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills - Strong analytical skills and the ability to solve problems through analytical reasoning. - Design for Reliability and Manufacturability (DRM) certification ASQ Certification in Quality or Reliability 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) Additional Information - Posting Date: May 25, 2021 - Travel: No
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