Abbott Engineer II, Systems in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
We are seeking an experienced, high caliber Systems Engineer II to be a self-starter working under minimal supervision to support product development efforts by performing systems engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of specific products and systems. The person filling this position will 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. The work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study, while demonstrating aspects of technical or organizational leadership within the assigned projects. The successful candidate must have the ability to apply technical, clinical and marketing understanding of issues to bring assigned tasks to resolution, applying engineering and scientific principles to the evaluation and solution of technical problems. An appropriate level of technical judgment shall be exercised in planning, organizing, performing and coordinating clinical-systems engineering assignments. Systems engineers are required to stay abreast of technical advancements and communicate them to colleagues and associates, and routinely use the most effective, cost efficient and best practices to execute processes.
Each employee can make a difference at Abbott and has the power, either individually or as a member of a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Duties and responsibilities:
Leads/owns pre-defined tasks within a larger effort such as definition, validation or product development of a sub-system, and drives them to on-time, high quality completion.
Leads/owns system level verification against requirements and validation against user need requirements. Creates test plans, procedures and reports, reviews the material with appropriate sub-system leads, performs and analyzes system set up, and conducts verification and validation activities.
Investigates and defines clinical requirements for new algorithms, and facilitates the transition of algorithms into new projects through clinical review and evaluation. Assesses the clinical and system risks of new algorithms and features, and identifies potential interactions with existing ones. Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of new algorithms.
Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications. Participates in broad cross functional review of work output. Updates and maintains feature specifications for one major project and may support one or more minor project.
Simulates or tests aspects of new projects or algorithms to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies. Defines and conducts storyboarding/beta testing to evaluate/measure customer acceptance of proposed product performance and operational characteristics. Analyzes and reports findings to immediate line management.
Investigates and defines clinical-systems engineering requirements for new algorithms or features, and facilitates the transition of algorithms into new projects through clinical review and evaluation.
Contributes to the evaluation and validation of a specific subsystem or project prior to submission.
Provides input into the development of clinical system validation plans, and conducts those tests.
Interacts with functional groups as necessary to conduct feasibility studies, technology assessments, concept studies, or benchmarking studies.
Identifies and resolves issues, escalating as appropriate.
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.
Performs other related duties and responsibilities, on occasion, as assigned.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
Bachelor of Science in Biomedical Engineering, a related engineering field, or equivalent, including relevant coursework and/or work experience in product development.
Minimum of 2 years of relevant, progressively more responsible work experience in product development and/or a graduate degree with relevant project experience.
Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work as an individual contributor, within a team, and have proven leadership capability
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
Ability to maintain regular and predictable attendance.
Your preferred qualifications and education:
Medical device industry experience preferred.
Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, Software Engineering, preferred.
Professional certification or designation preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org