CAIRE Inc. · 1 week ago
Sr. Mechanical Engineer - Compressor
Ball Ground, GA
Full-time
Onsite
Senior Level
5+ years expCAIRE Inc. is focused on designing and developing high-quality oxygen concentrators. The Senior Mechanical Engineer will provide technical expertise in new product design and development, collaborating with cross-functional teams to ensure product reliability and compliance with medical device standards.
Health CareMedical Device
Responsibilities
Design and develop oxygen concentrators, focusing on functional and performance excellence
Apply advanced engineering methodologies, including statistical analysis, tolerance analysis, and design quality techniques, to ensure product reliability and robustness
Ensure compliance with ISO13485, IEC60601, IEC80601, and other medical device standards as required by FDA and other regulatory agencies
Collaborate cross-functionally with electrical engineers, industrial designers, and other stakeholders to optimize designs for manufacturability and serviceability
Integrate cost-conscious strategies, balancing functionality with design-to-cost initiatives
Design plastic components, working closely with injection molding suppliers to achieve high-quality production standards
Develop system architecture and oversee system integration efforts to ensure cohesive product functionality
Conduct design verification activities, including simulations and tests, to validate designs and ensure adherence to regulatory and safety standards
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
Bachelor's or Master's degree in Mechanical Engineering or a related field
5-8 years of experience in product design and development, particularly in medical devices or similar industries
Proficiency in modern design methodologies, including tolerance analysis, statistical analysis, design-to-cost, and design for manufacturability
Strong experience with CAD software (e.g., SolidWorks, CATIA, or equivalent) and simulation tools
Familiarity with regulatory requirements and standards for medical devices, including ISO13485, IEC60601, IEC80601, and FDA requirements
Expertise in designing plastic parts and collaborating with injection molding suppliers
Proven ability in system architecture development and system integration
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 with compressor designs and optimizations, especially for applications in the respiratory field
Familiarity with sustainability practices in product design
Experience in designing compact and portable devices
Knowledge of airflow and filtration systems
First-hand knowledge and experience of common manufacturing processes such as injection molding, die casting, machining, etc
First-hand knowledge and experience with simulation modeling (i.e. finite element analysis)
Understanding of manufacturing factory metrics and Six Sigma principles
Awareness and understanding of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 9001 knowledge and experience
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