Senior Systems Engineer

Diality; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Diality is seeking a Senior Systems Engineer to lead cross‑functional teams through design control for the Moda-flx Hemodialysis System. You will drive DHF deliverables, risk management (ISO 14971), and V&V planning across hardware and software components.

The role requires a strong background in medical device regulations, full product lifecycle experience, and excellent collaboration across stakeholders to ensure quality and compliance in a cutting-edge dialysis technology environment.

Qualifications

• Bachelor's degree in biomedical, electrical, mechanical, systems or software engineering.
• Minimum 5 years of related experience or 3 years with a Master’s in engineering.
• Solid systems engineering experience across the product lifecycle with requirements management and traceability.
• Strong experience in risk management methodologies (FMEA, fault tree analysis) for medical device development.
• Experience in design verification and validation activities per regulatory requirements.

Responsibilities

• Lead cross‑functional team through the design control process.
• Complete DHF documentation deliverables (PRD, System Architecture Document, System Hazard Analysis, FMEA).
• Collaborate with stakeholders to decompose User Need requirements into product and subsystem requirements.
• Lead the risk management process in compliance with ISO 14971.
• Develop verification and validation test plans and coordinate testing with internal teams and external partners.
• Develop and validate test methods to verify product level requirements.
• Perform system level verification testing to ensure requirements and standards are met.
• Lead investigations into complex technical issues related to hardware/software sub‑components.
• Apply root cause analysis (RCA) and FMEA to identify causes and implement corrective actions.
• Share knowledge and best practices to cultivate a learning culture within engineering.

Skills

Medical device regulations

Systems engineering

FMEA / FTA

Requirements management

Python

MATLAB

Communication

Project delivery

Education

B.S. in biomedical, electrical, mechanical, systems or software engineering

Tools

SolidWorks

Minitab

Job description

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.

Responsibilities

• Lead cross‑functional team through the design control process.
• Complete DHF documentation deliverables including Product Requirement Specification, System Architecture Document, System Hazard Analysis, and Failure Modes and Effects Analysis.
• Collaborate with stakeholders to decompose User Need requirements into product level and subsystem level requirements.
• Lead the risk management process in compliance with ISO 14971.
• Strategize and develop verification and validation test plans to ensure product requirement specifications are met; coordinate testing activities with internal teams and external partners to meet V & V testing deliverables.
• Develop and validate test methods to appropriately verify product level requirements.
• Actively perform system level verification testing to ensure systems meet product level requirements and standards.
• Lead investigations into complex technical issues or failures related to hardware/software sub‑components.
• 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.
• Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.

Required Skills & Abilities

• Expert knowledge of medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
• Proficiency in engineering tools (e.g., SolidWorks, Minitab).
• Demonstrated proficiency in scripting languages (e.g., Python, MATLAB) and other software languages.
• Strong problem‑solving skills with the ability to conceptualize and develop innovative engineering solutions to complex technical challenges.
• 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.

Education & Experience

• Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering.
• Minimum 5 years of related experience or 3 years and a Master’s degree in engineering.
• Solid systems engineering experience across the entire product lifecycle, with proficiency in tools such as requirements management, change control, and traceability analysis.
• Strong experience in risk management methodologies (e.g., FMEA, fault tree analysis) and their application to medical device development and regulatory compliance.
• Strong experience in managing product and subsystem‑level requirements throughout the development process.
• Experience in conducting design verification and validation activities, including protocol development, testing, and documentation, in accordance with regulatory requirements.
• Experience in system architecture design and control system design.

Travel

N/a

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Must be able to access all areas of the facility to determine needs.

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.