Senior Mechanical Engineer - Cryogenic Liquid Oxygen Systems

CAIRE Inc.; Ball Ground (GA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Cryogenic systems

Mechanical design

Project management

Analytical skills

Communication

Leadership

Documentation

Ausbildung

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Creo

Simulation/analysis software

Jobbeschreibung

CAIRE 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.

The ideal candidate brings a proven track record in cryogenic vessel design, system-level integration, and collaboration with contract manufacturers to define sub-assemblies such as dewars, pressure regulation modules, and insulated containers for medical-grade liquid oxygen use.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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:
• 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.

Competencies/Success Factors

• Mechanical Skills
• Project/ Task Management
• Analytical Skills
• Team Orientation
• Coaching/ Developing Others
• Problem-Solving
• Leadership

Supervisory Responsibility

Responsible for leading, coaching, and directing other engineers.

This job operates in a professional office environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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.

Travel

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

Required Education and Experience

• 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 Education and Experience

• 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.

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.