CAIRE Inc. · 1 day ago
LOX Product Engineer - Contractor
Ball Ground, GA
Full-time, Contract
Onsite
Senior Level
$45/hr - $55/hr
5+ years expCAIRE Inc. is a company specializing in Liquid Oxygen medical products, and they are seeking a LOX Product Engineer to support manufacturing processes. The role involves validating manufacturing processes, authoring documentation, and ensuring compliance with quality systems.
Health CareMedical Device
Responsibilities
Responsible for Device Master Revord (DMR) deliverables - validation and qualification of new product launches, manufacturing equipment, software and processes leveraging standard qualification approaches (IQ/OQ/PQ)
While utilizing lean manufacturing tools, design, sustain and improve manufacturing assembly lines, refining BOMs, workflow processes, PFMEAs and detailed work instructions
Create and manage production changes through Engineering Change Orders (ECO)
Maintain compliance with medical device quality system which includes leading and/or supporting corrective action Preventative action initiatives (CAPAs), discrepant material disposition and Engineering Change Order (ECO) implementation
Provide technical support for failure analysis and root cause investigation of product failures
Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction, utilizing a DMAIC and DMADV structure
Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures
Improve product quality, yields, and reduce cost
Complete cost analysis and lead cost reduction efforts
Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing
Provide production line support for day-to-day engineering issues on core equipment
Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns
Other related duties
Qualification
Required
Minimum B.S. degree in engineering discipline
Successful experience leading projects, and juggle multiple business demands
Minimum of five years' engineering experience manufacturing cryogenic medical products, or complex electro-mechanical products
Experience with mechanical CAD (Solidworks, CREO), MS Project software
Experience in using Minitab for statistical analysis, Gage R&R
Experience with programming languages such as Java, Python and SQL
Experience developing products from concept to volume manufacturing
Mechanical design and analysis expertise desired
DMAIC and Lean Six Sigma experience, black belt preferred
Prior responsibility for validation of processes, equipment and products
Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk/Cp
Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers
Ability to work in a Matrix org structure with cross functional Value Streams
Preferred
Experience in an ISO 18777, ISO 13485, ISO 9001, or medical device manufacturing environment preferred
Cryogenics (Heat transfer, Thermodynamics) knowledge is a plus
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