System Engineer I

Systems Engineer IAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.The OpportunityWe are recruiting a Systems Engineer I to join our Abbott Heart Failure team in Pleasanton, CA, Burlington, MA or Atlanta, GA where we are focused on helping people with heart failure manage their health to ultimately change and save lives. The engineer will be primarily working on the CardioMEMS HF portfolio, which remotely monitors changes in pulmonary artery (PA) pressure, which is used to prevent worsening heart failure, lower heart failure mortality rates, and improve quality of life for our heart failure patients. Systems engineering defines, designs, tests, and integrates components, disciplines, and products within the CardioMEMS HF System, including implantable sensors, external reader systems used by clinicians and patients, mobile application software, and cloud-based web applications. The System Engineer will help execute tasks during design change projects and development of next generation products, including requirements definition and management, design documentation, and system testing, verification, and validation.What You'll Work OnAnalyzes input requirements for medical devices and translates these into specific system requirements and interface specifications. Documents system requirements using requirement management tools, and supports requirement development by writing documents, reports, memos, change requests, etc. Updates and maintains feature specifications in narrowly defined areas for specific projects.Participates in and contributes to the broad cross functional review of various design documentation and analyses. Presents systems engineering documentation and analyses in review meetings.Plans, coordinates, and develops system evaluation and testing activities based on analysis of system requirements, user needs, and system design.Simulates or tests aspects of new products or algorithms to evaluate prototypes, verify the design meets requirements, and validate whether performance and output meet customers' intended use requirements.Provides input into the development of system verification plans and procedures. Executes procedures to conduct those tests. Documents results and writes test reports that demonstrate safety and efficacy of the tested product and are reviewed by regulatory bodies.Conducts feasibility studies, benchmarking studies, reliability testing, and/or interaction testing.Assists in troubleshooting issues to determine root cause and possible engineering solutions.Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving system-level issues.Uses strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes, and meets deadlines in timely manner. Uses strong organizational and follow-up skills, as well as attention to detail, to complete tasks.Works within a team and as an individual contributor with generalized supervision in a fast-paced, changing environment. Works with independence, with minimal supervision and direction, demonstrating initiative and proactiveness.Required QualificationsBachelor's Degree in Engineering (Biomedical, Mechanical, Computer, Electrical, or Software), Computer Science, or related disciplinePreferred Qualifications6 months' experience in medical product developmentAdvanced Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related disciplineClass III implantable medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc)Experience and expertise with systems consisting of hardware, software, mobile app, and cloud componentsExperience and expertise with systems with RF, electromagnetics, ASICs, Bluetooth, and NFC technologiesKnowledge of a development process consistent with ISO, FDA design control standards or requirements, and risk management practices.Experience effectively integrating information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs