Mechanical Engineer

Katalyst CRO; Spokane (WA); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a technical lead for mechanical design in electromechanical medical device programs, guiding the full product lifecycle from concept through to production and manufacturing integration.

You will ensure regulatory compliance and oversee design reviews, cross-functional collaboration, and manufacturing integration to drive robust, compliant medical devices.

Qualifications

• Bachelor's or Master's in Mechanical Engineering required.
• 8+ years of medical device product development experience.
• Strong CAD proficiency and knowledge of electromechanical integration in regulated environments.

Responsibilities

• Lead mechanical design across product lifecycle from concept to production.
• Ensure regulatory compliance and quality through design reviews and risk management.
• Coordinate cross-functional collaboration with manufacturing, quality, and systems teams.

Skills

Mechanical design

Electromechanical integration

Risk management

Thermal analysis

Regulatory standards

Medical device development

GD&T

IS0 13485

FDA 21 CFR 820

ISO 14971

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Creo

Job description

Act as the technical lead for mechanical design in electromechanical medical device programs, overseeing the full product lifecycle from concept to production. Ensure compliance with regulatory standards while managing cross-functional collaboration, design reviews, and manufacturing integration.

Requirements

Requires a Bachelor's or Master's degree in Mechanical Engineering and over 8 years of experience in medical device product development. Candidates must possess strong proficiency in CAD tools and deep knowledge of electromechanical integration and regulated manufacturing environments.

Key Skills

Mechanical design, Electromechanical integration, SolidWorks, Creo, GD&T, ASME Y14.5, Tolerance stackup, DFM, DFA, FEA, ISO 13485, FDA 21 CFR 820, ISO 14971, Risk management, Medical device development, Thermal analysis