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Our location in Sylmar, CA, currently has an opportunity for a Software Requirements Engineer. The Software Requirements Engineer will be working under general supervision, supports product development efforts by performing Software -systems engineering tasks such as investigating, defining, analyzing, documenting 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 Software-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. May be involved in the testing activities associated with specific projects.
WHAT YOU’LL DO
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.
- Investigates and defines clinical, functional and technical requirements for new algorithms and features and facilitates the transition of algorithms into new projects through clinical review and evaluation. 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 Software-systems engineering requirements for new algorithms or features and facilitates the transition of the features into new projects through required reviews and evaluation.
- Contributes to the evaluation and validation of a specific subsystem or project prior to submission.
- Provides input into the development of software verification 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.
EDUCATION AND EXPERIENCE YOU’LL BRINGRequired
- Bachelors Degree in Biomedical Engineering or a related engineering field OR an equivalent combination of education and work experience
- Minimum 2 years Relevant, progressively more responsible work experience analyzing, defining and documenting requirements, preferably in a regulated environment
- Ability to travel approximately 10%, including internationally.
- Masters Degree in In a relevant discipline/concentration, including Biomedical Engineering, preferred. With relevant project experience preferred.
- Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred.
- Professional certification or designation 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. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
WHAT WE OFFERAt 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
- 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:
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.
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