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Senior Product Development Systems Engineer
4 months ago
The Opportunity
This position works ONSITE out of our Sylmar, CA location in the Cardiac Rhythm Management.
We are seeking a high-caliber Senior Product Development Systems Engineer that will focus on Abbott’s line of Remote Monitoring products for treating and monitoring cardiac arrhythmias and heart failure.
What You’ll Work On
The candidate in this role works to ensure our implantable devices can be monitored by our cloud services, Merlin.net web application and our line of patient transmitters and mobile apps. Working under general supervision, supports product development efforts by performing systems engineering tasks such as investigating, designing/defining, analyzing, and documenting Remote Monitoring algorithms and behavior. In addition, supports testing activities associated with these products. Performs 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. 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. Demonstrates aspects of technical or organizational leadership within the current projects. Has the ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises appropriate level of technical judgment in planning, organizing, performing and coordinating systems engineering assignments. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes.
Leads/owns pre-defined tasks within a larger effort such as definition or product development of a sub-system, and drives them to on-time, high quality completion.
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 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.
Investigates and defines 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 the conduct of 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.
Support 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.
Required Qualifications
Bachelors Degree in Biomedical Engineering, Computer Science, or a related engineering field.
Minimum 6 years Relevant, progressively more responsible work experience in medical product development.
Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required
Preferred Qualifications
Masters Degree In a relevant discipline/concentration, including Biomedical Engineering or Computer Science preferred. With relevant project experience preferred r an equivalent combination of education and work experience
Professional certification or designation preferred.
Medical device industry experience preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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.
Ability to travel approximately 5%, including internationally.
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