CAIRE Inc. · 1 day ago
Senior Sustaining Engineer
Ball Ground, GA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expCAIRE Inc. is a company focused on medical oxygen products, and they are seeking a Senior Sustaining Engineer to ensure the technical health and regulatory compliance of their product portfolio. The role involves leading engineering changes, collaborating with quality assurance, and sustaining product performance throughout its lifecycle.
Health CareMedical Device
Hiring Manager
Jordan Ochoa
Responsibilities
Lead and execute engineering changes (ECOs) for production oxygen concentrators and liquid oxygen systems to address component obsolescence, supplier changes, quality issues, regulatory updates, and manufacturing constraints
Act as a primary engineering responder for manufacturing line disruptions, driving rapid root cause analysis and timely corrective actions
Sustain and improve portable, transportable, and stationary concentrator platforms, ensuring long-term performance, reliability, and compliance
Sustain liquid oxygen delivery systems (e.g., Liberators, Helios), addressing mechanical, thermal, pressure, and system-level issues inherent to cryogenic oxygen delivery
Work in close collaboration with Quality Assurance to ensure sustaining changes are data-driven, risk-informed, and compliant, including:
Defining and justifying statistically sound sample sizes for verification, validation, and production-impacting changes
Applying appropriate statistical methods (e.g., confidence intervals, hypothesis testing, reliability sampling) to support engineering decisions
Leading and updating risk management activities, including DFMEA and PFMEA, to assess design and process risks associated with sustaining changes
Supporting investigations related to nonconformances, complaints, CAPAs, and post-market surveillance, ensuring robust root cause analysis and effective corrective actions
Ensure sustaining solutions align with ISO 13485, FDA QSR, ISO 14971, and applicable international regulatory requirements
Manage CAD models and controlled drawings using SolidWorks and/or CREO, ensuring configuration control and documentation accuracy
Identify, qualify, and implement alternate components and suppliers, ensuring form-fit-function equivalency and regulatory acceptability
Collaborate with Manufacturing Engineering, Supply Chain, Regulatory Affairs, and Operations to implement changes that maintain quality, reduce risk, and ensure uninterrupted production
Drive cost-reduction, manufacturability, and reliability improvements while maintaining patient safety and regulatory compliance
Interface with New Product Development (NPD) teams to support design transfer, ensure manufacturability readiness, and maintain continuity across the product lifecycle
Support updates to production, service, test, and risk documentation as required by sustaining changes
Other duties and responsibilities as assigned by management
Qualification
Required
Bachelor's degree in Mechanical Engineering or related engineering discipline
8+ years of experience in medical device engineering, with substantial experience supporting production
Proficiency in SolidWorks and/or CREO for CAD modeling and drawing management
Demonstrated experience executing engineering changes in regulated environments
Strong working knowledge of medical device quality systems, risk management, and statistical methods
Preferred
Master's degree in Mechanical Engineering or related engineering discipline
12+ years of experience in medical device engineering, with substantial experience supporting products in production
Experience with respiratory devices, oxygen concentrators, or liquid oxygen delivery systems
Familiarity with manufacturing processes including machining, forming, welding, assembly, and pressure-containing systems
Experience supporting global manufacturing operations and supplier networks
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