Senior Mechanical Engineer

The Senior Mechanical Engineer provides technical expertise in new product design and development projects. The engineer will be tasked design and development activities as well as sustaining and manufacturing support type tasks. The engineer will be part of a cross functional design team and will be responsible for supporting projects and products throughout the entire life cycle.

This position will focus on designing and developing high-quality oxygen concentrators, leveraging modern design methodologies such as design quality, statistical analysis, tolerance analysis, design-to-cost, and design for manufacturability, serviceability, and sustainability. This role requires familiarity with key medical device standards and expertise in system architecture, integration, and design verification.

Essential Functions

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

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.

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.

Work Environment

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

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 Education and Experience

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.

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.