CAIRE Inc. · 3 days ago
Sr. Mechanical Engineer - Cryogenic Liquid Oxygen Systems
Ball Ground, GA
Full-time
Onsite
Senior Level
6+ years expCAIRE 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 role is critical in ensuring the safety, reliability, usability, and cost-effectiveness of liquid oxygen storage and delivery systems, adhering to FDA-recognized medical device standards.
Health CareMedical Device
Responsibilities
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 (e.g., stainless steel, composites, thermal insulators)
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
Region specific localization of welded vessels (Sheet metal thickness and welding method)
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
Utilize feedback from customers and service teams to improve product designs and enhance user experience
Incorporate insights from designs by other manufacturers into the development process for continuous improvement
Document design processes, analysis results, and lessons learned for knowledge management and ongoing enhancement
Qualification
Required
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 (e.g., dewar systems, vacuum chambers)
Proficient in GD&T, tolerance stack-ups, and defining critical-to-quality (CTQ) dimensions and inspection criteria
Proficiency with CAD tools (e.g., SolidWorks, 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 (replacing ISO 18777), 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
Ability to incorporate knowledge from designs by other manufacturers into development workflows
Exceptional problem-solving skills, attention to detail, and ability to manage multiple projects
Excellent communication and documentation skills
Preferred
Experience designing liquid oxygen delivery systems, cryostats, or medical gas systems
Familiarity with hazard analysis, FMEA, and risk management per ISO 14971
Hands-on experience with test instrumentation, data acquisition, and reliability validation for cryogenic systems
Knowledge of DFx, DFMEA, and lean product development
Background in designing for low-temperature fluid dynamics, including phase change behavior and safety release mechanisms
Experience with product transfer to manufacturing and ramp-up in highly regulated environments
Understanding of manufacturing factory metrics and Six Sigma principles
Company
CAIRE Inc.
CAIRE Inc.
501-1000 employees
H1B Sponsorship
CAIRE Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$41MKey Investors
NGK SPARK PLUG COFosun Pharma
2020-06-03Acquired
2018-01-08Series C· $15M
2016-06-30Series C· $17.4M
Leadership Team
Barry Hassett
Chief Commercial Officer
Company data provided by crunchbase