Company & Job Overview:

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Staff 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.
• 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.
• Conducts engineering activities 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.
• 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.
• Documents and analyze design requirements for implementation.
• Designs, models, simulates and tests complex 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.
• Ensures all the design activities and documents meet the regulatory and QMS requirements.

Required Skills & Abilities

• 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.
• Strong problem-solving skills with the ability to conceptualize and develop innovative engineering solutions to complex technical challenges.
• Understanding of design for manufacturability and reliability, with full product life cycle experience.
• 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.
• Show high initiative and collaboration, be self-motivated, and have ability to act independently on technical matters.

Education & Experience

• Bachelor’s degree in science or engineering.
• Minimum 8 years of related experience or 6 years and a Master’s degree
• Knowledge of FDA QSR, ISO 13485, ISO 60601, ISO 14971, experience with test and troubleshooting of electrical safety and EMC is a plus.
• Experience in hemodialysis/hydraulic electrical system design, familiar with motor driver design, sensor signal processing is a plus.
• Experience with project or technical management is a plus..

Travel

• Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.

Physical Requirements

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

• Some lifting of<25 pounds