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Principal Electrical Engineer - Irvine, United States - Diality
Description
Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.
The Principal Electrical Engineer will have an exciting opportunity to architect and develop novel electrical systems for hemodialysis devices in a fast-paced design environment. You'll collaborate with a cross-functional team to develop our flagship product from concept through commercialization. This role requires your thorough understanding of electrical engineering principles and practices. Additionally, the role involves performing technical planning, system integration, verification and validation, cost and risk analysis, and supportability and effectiveness analyses for total systems. The ideal candidate will be a hands-on engineering expert and a technical leader who drives the continuous improvement of innovation, quality, delivery and productivity within the R&D organization.
Responsibilities:
Provides solutions to various issues in creative and effective ways.
Directs the application of existing principles and guides development of new policies and ideas within the function.
Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.
Take full responsibility for all aspects of electrical design to ensure product features, performance and quality are met within the cost budget and delivered on time.
Identifies and specifies electronic subsystems and boards.
Documents and analyzes design requirements for implementation.
Design, model, simulate and test complex electronic circuits, subsystems and systems.
Create schematic drawings, support PCB layout, generate BOMs and build packages, and coordinate with contract manufacturer on board fabrication and assembly.
Diagnoses and proposes solutions for electrical system issues.
Support system integration and troubleshooting, verification and validation, including safety, EMC and reliability.
Apply risk, failure analysis, and root cause analysis as required within the engineering discipline.
Works with production to ensure manufacturability and testability of electrical designs.
Ensure all the design activities and documents meet the regulatory and QMS requirements.
Qualifications & Requirements:
Bachelor's degree in science or engineering
Minimum 8-12 years of related experience in complex electromechanical system design for Medical Devices
Proficient with electronic circuits design, including power, analog and digital components and applications.
Proficient with EDA tools to do schematics and layout design.
Proficient with lab instruments to do measurement and troubleshooting.
Understanding of design for manufacturability and reliability, with full product life cycle experience (medium to high volume).
Knowledge of IEC60601 series standards, experience with test and troubleshooting of electrical safety and EMC.
Understanding of Medical Device QMS and design control, familiar with PDM/PLM system and change control process.
Excellent communication and presentation skills
Show high initiative and collaborative, be self-motivated, and have ability to act independently on technical matters.
Experience in hemodialysis/hydraulic system design, familiar with motor driver design, sensor signal processing is a plus.
Experience with project or technical management is a plus.
Physical Demands:
Sustained periods of time standing and sitting in a laboratory
Sitting at a desk utilizing a computer
Some lifting of<25 pounds
Working Environment:
Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.
Travel:
Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.