PRINICIPAL ELECTRICAL ENGINEER - Abbott Laboratories / Irving, TX
Responsible for independently performing and overseeing tasks related to the execution of new and existing medical device products, processes, proto@types, fixtures, and tools. Apply advanced multidisciplinary engineering knowledge to design and develop innovative medical devices and complex subsystems in support of business strategies. Provide broad technical leadership and effective engineering solutions in area of expertise. Execute continuous quality improvement and is the technical lead for multiple subsystems and/or instrument projects. Demonstrate broad product expertise and technical leadership for multiple subsystems of an instrument platform. Communicate (verbally and in writing) technical details to cross-functional team members, site and/or senior management, and suppliers, regulatory bodies, customers, and other external parties. Lead the development of designs for new and existing systems in accordance with applicable procedures and medical regulatory standards, perform analysis on design concepts, and tests theories to reduce risks. Establish requirements and specifications for medical devices, including justifications and supportive testing. Specify, design, verify and validate new medical devices to meet user needs. Apply understanding of design tools and techniques, including Six Sigma, Design for Manufacturability (DFM), and Analytical Design, to improve products and processes used in design and manufacturing and develop and execute new medical devices, processes, equipment, materials, verification, and validation.
Use experimental, empirical, and numerical analyses to evaluate designs and perform engineering analysis with simulation tools to mitigate design risks and ensure new design reliability
. Lead test method and simulation model development using electrical circuit design tools, programmable logic device design tools, and electrical engineering lab equipment, including oscilloscopes, digital multimeters (DMMs), power analyzers, and related equipment
. Design digital and analog products, including microprocessor systems and communication subsystems, and motor control circuits in accordance with EMI/EMC standards
. Lead the development of product specifications, Failure Modes and Effects Analyses (FMEA), including design and process FMEA (dFMEA and pFMEA), Design of Experiments (DOEs), and verification and validation (VandV) protocols and plans, risk analyses, and manage risk management documents for the same
. Recommend and implement Design Control procedures for development in accordance with FDA and ISO guidelines, including FDA 21 CFR 820 and ISO 13485
. Apply theoretical principles, evaluation, ingenuity and creative / analytical techniques for assessment across sub-system level designs. Apply troubleshooting and root cause analysis (RCA) tools and techniques to troubleshoot multiple sub-system designs
. Provide written technical justifications and rationale for multiple sub-system designs. Use knowledge of engineering and cross-functional tasks and establishes overall engineering schedule. Provide ideas for process improvements and innovative concepts that drive engineering task efficiencies and apply them to On-Market and RandD projects. Lead technical design reviews of sub-system design, hardware, PCBA interface, production processes, and requirements documents
. Lead project discussions across site/organizations, including Reliability and System Performance across multiple cross functional teams. Work with internal cross-functional teams and external suppliers to develop proto@type parts, processes and test methods for parts and subassemblies. Provide site technical leadership and development of complex technical project plans and schedules covering all engineering activities, meeting all design control and product development SOP requirements. Provide training and/or mentorship to other engineers.
Masters or foreign equivalent degree in Electrical Engineering, Biomedical Engineering, or in a related engineering or scientific field of study (Will accept a Bachelors degree plus 5 years of progressive experience in lieu of a Masters degree). Each alternative requirement with at least 3 years of professional experience in: (i) applying understanding of design tools and techniques, including Six Sigma, Design for Manufacturability (DFM), and Analytical Design, to improve products and processes used in design and manufacturing and develop and execute new medical devices, processes, equipment, materials, verification, and validation; (ii) using experimental, empirical, and numerical analyses to evaluate designs and perform engineering analysis with simulation tools to mitigate design risks and ensure new design reliability; (iii) leading test method and simulation model development using electrical circuit design tools, programmable logic device design tools, and electrical engineering lab equipment, including oscilloscopes, digital multimeters (DMMs), power analyzers, and related equipment; (iv) designing digital and analog products, including microprocessor systems and communication subsystems, and motor control circuits in accordance with EMI/EMC standards; (v) leading the development of product specifications, Failure Modes and Effects Analyses (FMEA), including design and process FMEA (dFMEA and pFMEA), Design of Experiments (DOEs), and verification and validation (VandV) protocols and plans, risk analyses, and manage risk management documents for the same; (vi) implementing Design Control procedures for development in accordance with FDA and ISO guidelines, including FDA 21 CFR 820 and ISO 13485; (vii) applying troubleshooting and root cause analysis (RCA) tools and techniques to troubleshoot multiple sub-system designs; and (viii) leading technical design reviews of sub-system design, hardware, Printed Circuit Board Assembly (PCBA) interface, production processes, and requirements documents. Employer will accept any suitable combination of education, training, or experience.
An EOE. 40 hrs/wk. Apply on WorkinTexas or send Resumes to: Abbott Laboratories, Elvia Salazar, Willis Tower, 233 S. Wacker Drive, Floor 25, Dept. 32, Chicago, IL 60606. Refer to ad code: ABT-0097-ES
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