Senior Software Quality Engineer

This position has the responsibility and authority to work with minimal guidance to support the design, development, test, and market release of Product software used in real time Imaging System. Contribute to non-product software process, test equipmenet  development and validation process. Develop and assess the quality programs and systems of Medtronic Navigation to applicable standards. Do meaningful work, make a difference, and improve lives -- starting with your own.   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. A Day In The Life oActively participate in product development cycle by reviewing software project documentation and participating in product risk assessmentsoWork cross-functionally to implement improvements to the software 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 techniquesoCreate and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System related to software and system designoIdentify 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-releaseoReview documentation for validation and maintenance of non-product Software utilized in production environment, automated test equipment and quality system. Update policies and SOPs to ensure they comply with applicable regulations and standardsoRecommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and analysis are completed in a timely manner in accordance with FDA and European Regulatory agency standards and proceduresoProvide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectivesoConduct risk management activities and recommend an appropriate course of action via CAPA systemsoParticipate in Post Market Monitoring activities such as complaint investigation, complaint trending etc.oFollow all Quality System Practices as defined by Medtronic Navigation's Littleton's practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicableoParticipate in DHF audits and conduct independent review of product verifications and validations.  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. Must Have: Minimum Requirements EDUCATION REQUIRED:  oBachelors in Engineering or similar related field, but Computer Science Preferred YEARS OF EXPERIENCE:  o4+ years of previous experience in an engineering position with Bachelorso2+ years of previous experience in an engineering position with Masters SPECIALIZED KNOWLEDGE REQUIRED:  oExperience in a Regulated environment 18000J83
Salary Range: NA
Minimum Qualification
Less than 5 years

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