Principal Software Design Quality Engineer
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Prin. Software Design Quality Engineer
Medtronic ENT (Ear, Nose, and Throat) is an operating unit within Medtronic’s Neuroscience Portfolio. The unit focuses on providing innovative solutions for ENT conditions, including surgical and therapeutic products designed to improve patient outcomes in ear, nose, and throat health.
We are currently offering an excellent opportunity to join the ENT Quality team as a Prin. Software Quality Engineer. This position is based onsite in Jacksonville, FL.
In this role, you will serve as an individual contributor with responsibilities in our technical functions to advance existing technology or introduce new technologies and therapies. You will be tasked with formulating, delivering, and managing assigned projects, collaborating with other stakeholders to achieve desired results. You may mentor colleagues or direct the work of lower-level professionals. Your primary focus will be on delivering research and development, systems, or initiatives related to new technologies or therapies—from design to implementation—while adhering to policies, utilizing specialized knowledge and skills, and continuously improving products and processes. This position involves providing design quality engineering support for the software design and development of medical devices, stand-alone software of non-products, non-devices, and components, including firmware. Additionally, you will facilitate the application of design controls in product development and released product management.
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 software quality. Develops and maintains quality and reliability metrics.
Works on software reliability controls including reliability prediction, stress and performance testing for software.
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.
Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk management documentation, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety.
Participate and review cybersecurity documents such as SBOM, STRIDE analysis and Penetration testing.
Follow all Quality System Practices as defined by Medtronic Navigation’s practices, pol
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