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CAIRE Inc.

Senior Mechanical Engineer - Compressor

CAIRE Inc., Ball Ground, Georgia, United States, 30107

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Overview

Senior Mechanical Engineer - Compressor/Pneumatics/Plastics at CAIRE. Provides technical expertise in new product design and development projects, with responsibilities across design, development, sustaining and manufacturing support. Works within a cross-functional design team to support projects and products through the entire life cycle. Focuses on designing and developing high-quality oxygen concentrators, leveraging design methodologies such as design quality, statistical analysis, tolerance analysis, design-to-cost, and design for manufacturability, serviceability, and sustainability. Requires familiarity with key medical device standards and expertise in system architecture, integration, and design verification. Responsibilities

Design and develop oxygen concentrators, targeting functional and performance excellence. Apply advanced engineering methodologies (statistical analysis, tolerance analysis, design quality) 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. Incorporate cost-conscious strategies and design-to-cost initiatives. Design plastic components and collaborate with injection molding suppliers to achieve high-quality production standards. Develop system architecture and oversee system integration for cohesive product functionality. Conduct design verification activities, including simulations and tests, to validate designs and ensure regulatory and safety compliance. Support production by ensuring smooth transition from prototype to mass manufacturing while maintaining quality. Utilize customer and service feedback to improve product designs and user experience. Incorporate insights from designs by other manufacturers into the development process for continuous improvement. Document design processes, analyses, and lessons learned for knowledge management and ongoing enhancement. Qualifications

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 (tolerance analysis, statistical analysis, design-to-cost, design for manufacturability). Strong experience with CAD software (e.g., SolidWorks, CATIA, or equivalent) and simulation tools. Familiarity with regulatory requirements for medical devices (ISO13485, IEC60601, IEC80601, 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. Excellent problem-solving, attention to detail, and ability to manage multiple projects. Excellent communication and documentation skills. Preferred Education and Experience

Experience with compressor designs and optimizations, especially for respiratory applications. Familiarity with sustainability in product design. Experience in designing compact and portable devices. Knowledge of airflow and filtration systems. Experience with common manufacturing processes (injection molding, die casting, machining). Experience with simulation modeling (finite element analysis). Understanding of factory metrics and Six Sigma principles. Awareness of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 9001 knowledge. Additional Eligibility Qualifications

None required for this position. Other job details

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities. Duties may change at any time with or without notice. Equal Employment Opportunity

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. Job Details

Seniority level: Mid-Senior level Employment type: Full-time Industries: Medical Equipment Manufacturing Travel: Occasional travel as needed, including international travel for training and collaboration. Physical Demands: Refer to safety and accessibility guidelines; occasional lifting up to 50 lbs; standing, walking, bending, and other movements as required. Note: This posting may show related roles and alerts; ignore non-relevant sections and refer to CAIRE’s official postings for current opportunities.

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