Abbott Staff Systems Engineer R&D in Atlanta, Georgia
Abbott 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 109,000 colleagues serve people in more than 160 countries.
Staff Systems Engineer – R&D Atlanta, GA or Burlington, MA
As Staff System Engineer , you will focus on Abbott’s CardioMEMS Heart Failure System portfolio of products for treating and monitoring heart failure. You will ensure that our implantable devices can be monitored by our cloud services, Merlin.net HF web application and our line of patient transmitters and mobile apps. The Staff Systems Engineer will deliver systems engineering tasks for entire programs or significant portions of programs with some level of novelty. This role ensures the logical and systematic conversion of customer requirements and performance requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
The Staff Systems Engineer supports product development efforts by performing systems engineering tasks such as investigating, designing/defining, analyzing, and documenting Remote Monitoring algorithms and behavior. In addition, you will support testing activities associated with these products, perform additional analysis and/or interviews to determine the requirements and constraints on the assigned portion of the system and is accountable for resolving cross-functional issues.
In this role, you will apply your expert understanding of Systems Engineering methodologies, applications, the clinical environment, and architected solutions to streamline product development and improve product quality. This role is a leadership position that requires strong Systems Engineering and technical skills in a high visibility environment, including work with the product R&D team, program management, marketing, regulatory, quality, clinical customers, internal medical, and field support personnel. In turn, we will utilize your experience and knowledge to continue grow and expand the capabilities of the Systems Engineer team.
Serves as a subject matter expert for the development of Abbott’s CardioMEMS portfolio of products. This position will focus on the clinician facing web application and patient facing mobile application components of the CardioMEMS portfolio but will require an in-depth understanding of how the other components operate and interface within the product ecosystem.
Leverages Systems Engineering methodologies and product expertise to take new products and features through the entire product life cycle, from concept ideation to product commercialization.
Leads programs while exercising significant novelty and integration across various disciplines as well as team members. Applies a demonstrated portfolio-centric approach to developing programs which are incorporated into platform strategies that achieve “win/win” scenarios for assigned efforts and platforms.
Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, translates these into specific system requirements/interface specifications, and facilitate the transition of these requirements into products. Participates in broad cross functional review of work output.
In coordination with clinical engineers, medical directors, and product development teams, is a key contributor to risk management activities within R&D, including risk brainstorming, severity and probability assessments, development, and maintenance of Use FMEA, overall risk management planning and reporting. Assesses the clinical and system risks of new algorithms and features, and identifies potential interactions with existing ones.
Creates and executes system level verification and validation tests. Responsible for driving all system verification plans against system requirements. Responsible for helping craft use-case relevant test cases. Assists with usability validation.
Provides input into the development of clinical system validation plans, and the conduct of those tests.
Assists during development and integration process: reviews software requirements to ensure proper translation from system requirements, investigating issues during integration and testing
Works with Program Management and Senior Leadership to establish and manage project scope, schedule, and resourcing needs to ensure successful delivery of new and modified products.
Fosters collaboration with cross-functional teams, platform architects and other leaders to drive work to completion and resolve issues. Successfully influences stakeholders. Communicates effectively with cross-functional teams, senior management, and clinician and physician customers. Keeps leadership informed of progress and issues.
Plans and executes the department strategy to deliver upon responsibilities; gathers information, frames problems, devises/executes plans, tracks progress, and adjusts/measures success within scope of responsibility to improve development efforts as well as the organization. Applies skills to planning product development work; capturing requirements, designing solutions, defining behaviors, investigating issues, evaluating trade-offs, and validating output.
Organizes and manages work to deliver programs, leads in the execution of assigned work. Prioritizes tasks by distinguishing urgent from important tasks and assess cost/benefit trade-offs.
Innovates within program work to improve the organization, solve technical challenges, and develop intellectual property.
Stays abreast of and communicates technical advancements to colleagues and associates.
Identifies and resolves issues, escalating as appropriate.
Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Demonstrates aspects of technical or organizational leadership within the current projects.
Exercises appropriate level of technical judgment in planning, organizing, performing, and coordinating systems engineering assignments.
Routinely uses the most effective, cost efficient and best practices to execute processes.
Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE REQUIRED
Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or a related engineering field or an equivalent combination of education and work experience.
8+ years of in a similar position, including experience in the development of Class II or III medical devices, requirements elicitation, requirements definition, risk management, and system verification
Experience with large, complex web application and databases, cloud-based systems, and mobile applications
Experience and familiarity with “ISO/IEC/IEEE 15288:2015 – Systems and Software Engineering – System Life Cycle Processes”
Experience and familiarity with current Systems Engineering methodologies and associated tools/applications. (MBSE, SysML, UML, etc.)
Experience using requirements management tools (e.g. DOORS or equivalent), document management tools (e.g. Windchill or equivalent), and Microsoft Office tools such as Word, PowerPoint, Project, and Visio (or equivalents)
Experience working within a team and as an individual contributor in a fast-paced, changing environment
Experience working within an environment where mature engineering processes are defined and followed; and experience in optimizing existing processes to improve quality and efficiency
Experience working within quality system catered to medical device design controls
Possesses excellent verbal and written communication skills, with ability to communicate to all levels of the organization
Advanced Degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Computer Science. With relevant project experience preferred.
INCOSE Systems Engineering Professional Certification
Possess baseline knowledge of cybersecurity concepts and controls
Possess baseline clinical knowledge of cardiac function
Medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc)
Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs
Experience working in a highly matrixed and geographically diverse business environment
Experience in Human Factor Engineering
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Student Loan Repayment Assistance
Financial security through competitive compensation, incentives, and retirement plans
Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
_Learn more about our benefits that add real value to your life to help you live fully: _ www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
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