Principal Mechanical Engineer - Medical Device Systems Lead

Diality, Inc.; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Diality, Inc. is seeking a Principal Mechanical Engineer to lead the design and development of next-generation hemodialysis subsystems and disposable components.

You will move projects from concept to production, define architectures, and mentor internal engineers and external partners. The role requires hands-on engineering, strong CAD and DFM/DFA skills, GD&T, FEA, and experience with regulated medical devices.

Qualifications

• Deep expertise in mechanical design and development of complex electromechanical products, preferably in a regulated medical device environment.
• Experience with FDA design controls, including requirements, design reviews, verification plans, and DFMEA.
• Experience designing and releasing production injection‑molded components, with plastics, tolerancing, tooling, and first article inspection.

Responsibilities

• Provide technical leadership for mechanical development from concept through production.
• Lead mechanical architecture and design translating system requirements into robust solutions.
• Mentor internal engineers and coordinate with cross-functional teams including Systems, Electrical, Software, Manufacturing, Quality, and Regulatory.
• Perform hands‑on engineering work: CAD, prototyping, testing, and design optimization.
• Develop and maintain mechanical requirements, drawings, tolerances, and costed BOMs.
• Apply GD&T, FEA, and tolerance analysis to optimize designs for performance and cost.
• Lead verification activities and design reviews, contributing to risk management and DFMEA.
• Collaborate with suppliers and manufacturers to qualify production components and processes.

Skills

Mechanical design

Design controls

Injection molding

Electromechanical systems

GD&T

Prototyping

Manufacturing collaboration

Design optimization

Cross-functional leadership

Technical communication

Technical documentation

Systems thinking

Education

Bachelor's degree in Mechanical Engineering

Advanced degree preferred

Tools

SolidWorks

PDMWorks

Job description

Diality, Inc. is seeking a Principal Mechanical Engineer to lead the design and development of next-generation hemodialysis subsystems and disposable components.

You will move projects from concept to production, define architectures, and mentor internal engineers and external partners. The role requires hands-on engineering, strong CAD and DFM/DFA skills, GD&T, FEA, and experience with regulated medical devices.