Senior Principal Mechanical Engineer, Medical Devices

Diality; Irvine (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Diality is a medical device company focused on kidney disease solutions. The Principal Mechanical Engineer will provide technical leadership for next-generation hemodialysis subsystems and disposable components, moving projects from concept to manufacturing.

The role blends hands-on design with team leadership, requiring collaboration with Systems, Electrical, Software, Manufacturing, Quality, and Regulatory teams to deliver robust, cost-effective products.

Qualifications

• Deep expertise in mechanical design and development of complex electromechanical products, preferably within a regulated medical device environment.
• Experience with FDA design controls including requirements, design reviews, verification, risk analysis, and DFMEA.
• Demonstrated ability to design and release injection-molded components; strong understanding of DFM/DFA, tooling, tolerancing.

Responsibilities

• Provide technical leadership for the mechanical development of medical device systems and disposable components from concept through production.
• Lead mechanical architecture and design activities, translating system requirements into robust mechanical solutions.
• Serve as mechanical technical lead for major development programs and deliver technical objectives, priorities, and schedules.
• Hands-on engineering work including CAD, prototyping, testing, and design optimization.
• Mentor internal engineers and coordinate with external partners and suppliers.
• Collaborate across Systems, Electrical, Software, Manufacturing, Quality, and Regulatory teams.
• Develop mechanical requirements, specs, drawings, tolerances, and costed BOMs.
• Apply GD&T, FEA, and other analyses to optimize performance and cost.

Skills

Mechanical design

FMEA/DFMEA

GD&T

Prototyping

CAD/ SolidWorks

Design for manufacturing

Cross-functional leadership

Technical communication

Education

Bachelor's degree in Mechanical Engineering

Advanced degree preferred

Tools

SolidWorks

PDMWorks / PDM system

Job description

Diality is a medical device company focused on kidney disease solutions. The Principal Mechanical Engineer will provide technical leadership for next-generation hemodialysis subsystems and disposable components, moving projects from concept to manufacturing.

The role blends hands-on design with team leadership, requiring collaboration with Systems, Electrical, Software, Manufacturing, Quality, and Regulatory teams to deliver robust, cost-effective products.