Company & Job Overview:

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 Senior Electrical Engineer will be responsible for troubleshooting system issues for hemodialysis devices. Responsibilities include assessing system complaints, performing root cause analysis, conducting tests and providing resolutions; creating and reviewing documentation and related drawings; designing electrical components, circuits or sub-systems of moderate difficulty; Additionally, the role involves planning and coordinating detailed phases of electrical and systems engineering activities for the assigned project, and participating sub-system integration, verification and troubleshooting.

Responsibilities:

• Lead investigations into complex technical issues or failures related to hardware/software sub-components.
• Diagnoses and proposes solutions for electrical system issues.
• Complete knowledge and full understanding of engineering, principles, and practices
• Devises solutions based on limited information and precedents and adapts existing approaches to resolve issues.
• Uses evaluation, judgment, and interpretation to select the right course of action.
• Enhance relationships and networks with senior internal/external partners who are not familiar.
• Conducts engineering activities 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 analyze design requirements for implementation.
• Strategizes and develops verification and validation test plans to ensure product requirement specifications are met. Coordinates testing activities with internal teams and external partners to ensure V&V testing deliverables are met.
• Designs, models, simulates and tests electronic circuits, subsystems and systems.
• Create schematic drawings, guides PCB layout, generates BOMs and build packages, and coordinates with contract manufacturer on board fabrication and assembly.
• Supports system integration and troubleshooting, verification and validation, including safety, EMC and reliability.
• Applies Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions.
• Works with production to ensure manufacturability and testability of electrical designs.
• Administrate electrical lab equipment, tools and materials; support board and cable rework and assembly; ensure the lab activities meet the safety and 5S requirements.

Qualifications & Requirements:

• Bachelor's degree in science or engineering
• Minimum 5 years of related experience or 3 years and a master's degree
• Familiar with electronic circuits design, including power, analog and digital components and applications.
• Familiar with EDA tools to do schematics and layout design.
• Familiar with lab instruments to do measurement and troubleshooting.
• Strong problem-solving skills with the ability to conceptualize and develop innovative engineering solutions to complex technical challenges.
• Good hand-on skills of reworking and cabling.
• Understanding of design for manufacturability and reliability.
• Knowledge of FDA QSR, ISO 13485, ISO 60601, ISO 14971, experience with test and troubleshooting of electrical safety and EMC is a plus.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization.
• Proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.

Physical Demands:

• Sustained periods of time standing and sitting in a laboratory
• Sitting at a desk utilizing a computer
• Some lifting of

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.