Senior Systems Engineer

Diality, Inc.; Irvine, Northern (CA, KY); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Diality, Inc. in Irvine, CA is seeking an experienced Systems Engineer to lead design control and risk management for the Moda-flx Hemodialysis system. This role focuses on DHF documentation and regulatory compliance across the product lifecycle.

You will coordinate V&V activities, guide cross-functional teams, and ensure product requirements are translated into verifiable designs and tests, in a collaborative medical device environment.

Qualifications

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

Responsibilities

• Lead cross-functional team through the design control process.
• Complete DHF documentation deliverables including Product Requirement Specification, System Architecture Document, System Hazard Analysis, FMEA.
• Collaborates with stakeholders to decompose User Needs into requirements.
• Lead the risk management process in ISO 14971 compliance.
• Develop verification and validation test plans and coordinate testing activities with internal and external teams.

Skills

Medical device regulations

FDA QSR

ISO 13485

ISO 60601

ISO 14971

SolidWorks

Minitab

Python

MATLAB

Problem solving

Communication

Project delivery

Education

Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering

Tools

SolidWorks

Minitab

Job description

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, Failure Modes and Effects Analysis
• Collaborates with stakeholders to decompose User Need requirements into product level and subsystem level requirements.
• Lead the risk management process in compliance with ISO 14971
• 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.
• Develops and validates test methods to appropriately verify product level requirements.
• Actively performs 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.

Requirements

Required Skills & Abilities

• Expert knowledge on 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, traceability analysis etc.
• 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.
• Has 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.