Sr. Mechanical Engineer - Cryogenic Liquid Oxygen Systems

Sr. Mechanical Engineer - Cryogenic Liquid Oxygen Systems

CAIRE Inc. is seeking a Senior Mechanical Engineer with deep expertise in the design, analysis, and development of cryogenic liquid oxygen tanks for medical device applications. This position plays a critical role in ensuring the safety, reliability, usability, and cost-effectiveness of our liquid oxygen storage and delivery systems, in compliance with FDA‑recognized medical device standards and regulations for oxygen handling.

• Lead the mechanical design of stationary and portable cryogenic liquid oxygen tanks and related assemblies, including inner and outer vessel structures, insulation systems, pressure relief and regulation mechanisms, and integrated interfaces for use in portable and stationary medical oxygen systems.
• Develop mechanical designs from concept through production, applying advanced engineering principles including requirements engineering, GD&T and ASME Y14.5 standards, tolerance stack‑up analysis, design for reliability, cost, manufacturability and safety, material selection for cryogenic and medical environments, and testing methodologies such as Helium Leak testing, Normal Evaporation Rate testing, Liquid Oxygen Mechanical Impact Sensitivity Testing.
• Collaborate closely with contract manufacturers (CMs) to define, source and validate key subassemblies including vacuum‑insulated dewars, welded assemblies and pressure‑bearing components.
• Ensure all designs comply with the latest revisions of ISO 13485, ISO/FDIS 18777‑1 (replacing ISO 18777), ISO 7396, ISO 21010, IEC 60601 and additional FDA requirements for medical oxygen systems and cryogenic safety.
• Define and execute test protocols for thermal performance, pressure integrity, vacuum retention and mechanical robustness.
• Lead root‑cause investigations, develop corrective actions and drive continuous product improvements across the product lifecycle.
• Interface with cross‑functional teams, including regulatory, quality, industrial design, service and marketing, to align design with user needs and market requirements.
• Maintain meticulous documentation, including Design History Files (DHF), inspection criteria, verification/validation reports, and regulatory submissions.
• Coach and mentor junior engineers and technicians on cryogenic system fundamentals and mechanical engineering best practices.
• Support the production team by ensuring smooth transitioning from prototype to mass manufacturing while maintaining quality.

• Mechanical Design Skills
• Project and Task Management
• Analytical Thinking
• Team Orientation
• Coaching/Developing Others
• Problem‑Solving
• Leadership

Responsible for leading, coaching, and directing other engineers.

This job operates in a professional office environment.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Occasional travel as needed, such as international travel to other sites and locations for training and collaboration purposes.

• 6+ years of experience in mechanical design with a focus on cryogenic systems or pressure vessels, ideally in the medical device industry.
• Demonstrated ability to work with and manage external contract manufacturers for complex subassemblies.
• Proficiency in GD&T, tolerance stack‑ups and defining critical‑to‑quality (CTQ) dimensions and inspection criteria.
• Proficiency with CAD tools (e.g., Solid Works, Creo) and simulation packages for thermal, structural and pressure analysis.
• Familiarity with welding processes, insulation techniques and cryogenic safety protocols.
• Knowledge of applicable standards: ISO 13485, ISO/FDIS 18777‑1, ISO 7396, ISO 21010, IEC 60601 and others relevant to cryogenic oxygen storage and medical devices.
• Experience in design verification processes, including simulation and testing.
• Exceptional problem‑solving skills, attention to detail and ability to manage multiple projects.
• Excellent communication and documentation skills.