Senior Systems Engineer

Diality Inc.; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Diality Inc. is seeking an experienced engineering professional to lead design control efforts for the Moda‑flx Hemodialysis system. You will drive DHF deliverables, decompose requirements, and manage risk per ISO 14971 across hardware and software components.

You will coordinate verification and validation activities, perform root cause analysis, and guide cross‑functional teams toward compliant, high‑quality medical device solutions.

Qualifications

• BS/BA in a relevant engineering field with 5+ years of related experience or 3 years with a Master’s degree.
• Solid systems engineering across the product lifecycle with requirements, change control and traceability.
• Experience with design verification/validation and regulatory requirements for medical devices.

Responsibilities

• Lead cross‑functional team through the design control process.
• Prepare DHF deliverables including PRS, System Architecture, System Hazard Analysis, and FMEA.
• Decompose User Needs into product and subsystem requirements.
• Lead risk management per ISO 14971.
• Plan and coordinate verification and validation testing with internal and external partners.
• Develop and validate test methods to verify product requirements.
• Perform system level verification testing to ensure compliance.
• Lead investigations into complex technical issues or failures.
• Apply RCA and FMEA to implement robust corrective actions.
• Share knowledge and lessons learned to foster engineering excellence.

Skills

Regulatory compliance

Engineering tools

Scripting languages

Problem solving

Communication

Project delivery

Education

Bachelor'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.