Systems Engineer IV

Abbott Laboratories•Alameda, CA

3d•$100,000 - $200,000

About The Position

Systems Engineer IV position is in our Alameda, California location. This individual will help establish and mature an enterprise-level systems engineering capability within our medical device organization. This role is responsible for defining, tailoring, deploying, and sustaining rigorous model-based systems engineering (MBSE) processes, methods, and tools across the product lifecycle. The role is responsible for continuous process improvement efforts in adopting, tailoring, and leveraging MBSE best practices that directly enhance project-based product development execution across the organization. You will play a crucial role in our MBSE transformation and ensure that our MBSE practices are practical, compliant, scalable, and value driven. Systems Engineer IV reports to our Manager of Systems Engineering and works closely with all parts of the business to help us deliver great products.

Requirements

Bachelor’s degree in engineering or physical science or related engineering field, or an equivalent combination of education and work experience
Minimum 6 years of product development experience
Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements.
Experienced in one or more of the following: Electro-mechanical, software, mathematical, chemical or biochemical technologies as they pertain to the design, integration, evaluation and commercialization of diagnostic systems
Experienced in SysML, Model Based Systems Engineering (MBSE) methodology, and system modeling tools. Experience in MBSE deployment a plus. Proficient in MagicDraw modeling software a plus. Certification in INCOSE ASEP/CSEP and/or SysML a plus.
Ability to work on many subjects concurrently

Responsibilities

Implement the MBSE vision, roadmap, and operating model in alignment with business needs – MBSE is an enabler of quality, speed, consistency, and predictability – not just a modeling exercise.
Architect, develop, and maintain an integrated system model for the system of interest and other relevant enabling systems, using Model Based Systems Engineering (MBSE) methodology and tools.
Establish and maintain MBSE standards, modeling conventions, modeling methods, and governance, including SysML profiles, modeling guidelines, and reusable model libraries.
Define how MBSE integrates with broader product development lifecycle processes (both engineering and Design Control), including requirements management, risk management, architecture definition, configuration management, interface management, and V&V (verification & validation)
Lead pilots and proof-of-concepts efforts to validate new techniques before broader deployment.
Perform project – based product development activities (with integration of MBSE practices), including but not limited to:
Perform product definition, system architecture, requirements management, risk analysis, hazard analysis, product test and evaluation, System V & V, and/or design control documentation.
Develop design processes.
Design and conduct system level characterization/verification of complex systems; collect, organize, analyze, and document test results.
Integrate analytical and performance related elements with software, hardware, and electronics system components.
Develop and execute model-based simulation tests in support of design characterization or product evaluation and testing.
Ensure traceability between requirements, architecture, risks, and verification & validation is robust, transparent, and auditable.
Communicate effectively and participate in cross functional development teams with good negotiating skills to direct multi-disciplinary teams toward solutions.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Failure to properly define requirements, integrate all systems, verify/validate requirements could result in product introduction delays and quality issues.
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.