Lead Mechanical Engineer, Cryogenic Oxygen Systems

CAIRE Inc.; Ball Ground (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

CAIRE Inc. seeks a Senior Mechanical Engineer to lead the design and development of cryogenic liquid oxygen tanks for medical devices. You will own detailed mechanical designs, drive reliability, and ensure regulatory compliance across ISO 13485 and FDA requirements.

Collaborate with contract manufacturers, perform GD&T, tolerance analyses, and guide test programs from concept to production while mentoring junior engineers and supporting manufacturing transition.

Qualifications

• 6+ years in mechanical design with cryogenic systems or pressure vessels, ideally in medical devices.
• Experience managing external contract manufacturers for complex subassemblies (dewar systems, vacuum chambers).
• Proficiency in GD&T, tolerance stack-ups, CTQ dimensions and inspection criteria.
• Proficiency with CAD tools (SolidWorks, Creo) and thermal/structural/pressure analysis simulations.
• Familiarity with welding, insulation, and cryogenic safety protocols.
• Knowledge of ISO 13485, ISO/FDIS 18777-1, ISO 7396, ISO 21010, IEC 60601 and related cryogenic/medical standards.
• Experience in design verification, simulation, and testing.
• Ability to incorporate external designs into development workflows.
• Strong problem-solving, attention to detail, and project management abilities.
• Excellent communication and documentation skills.

Responsibilities

• Lead the mechanical design of cryogenic liquid oxygen tanks and related assemblies from concept to production.
• Apply GD&T, tolerance analysis, and design for reliability, manufacturability, and safety.
• Select materials suitable for cryogenic/medical environments.
• Define and execute testing protocols (thermal, pressure, vacuum, mechanical).
• Collaborate with contract manufacturers to define, source, and validate subassemblies.
• Ensure compliance with ISO and FDA requirements for medical oxygen systems.
• Lead root-cause investigations and drive continuous improvement.
• Coordinate with regulatory, quality, industrial design, service and marketing teams.
• Maintain Design History Files, inspection criteria, validation reports, and regulatory submissions.
• Mentor junior engineers and support production transfer to mass manufacturing.

Skills

Cryogenic systems

Mechanical design

Project management

Analytical skills

Communication

Leadership

Documentation

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Creo

Simulation/analysis software

Job description

CAIRE Inc. seeks a Senior Mechanical Engineer to lead the design and development of cryogenic liquid oxygen tanks for medical devices. You will own detailed mechanical designs, drive reliability, and ensure regulatory compliance across ISO 13485 and FDA requirements.

Collaborate with contract manufacturers, perform GD&T, tolerance analyses, and guide test programs from concept to production while mentoring junior engineers and supporting manufacturing transition.