Mechanical Engineer Breathe Technologies

Breathe Technologies, Inc., is a developer and manufacturer of innovative medical technologies for treating lung diseases and sleep-disordered breathing. The company was founded in January 2005, and their ventilator, featuring the company?s proprietary, open-airway platform, is cleared for use in both the institutional and homecare settings. Breathe is in the process of relocating and is recruiting for positions based in Irvine, CA.
SCOPE OF POSITION:
Reporting to Director Research & Development (Ventilation), the Mechanical Engineer will lead projects of significant complexity and scope involving medical device systems and components. The position requires broad experience in developing products that contain mechanical and electromechanical devices and subsystems. In addition, this position requires a person that exhibits a high degree of technical competency, organization, and versatility. The position requires the ability to motivate others and the ability to work and communicate with others at all levels within the organization.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
? Manage the Mechanical Engineering development process through all phases of product development
? Providing the Mechanical Architecture level engineering
? Work closely with Q&A, Manufacturing, Regulatory, and System Engineering to establish and evolve the product requirements for new and existing products
? Work closely with vendors for components selection, purchasing, fabrication, assembly and testing
? Ensure that the company?s mechanical design efforts meet the product, process and schedule requirements
? Be contributor to invention disclosure and patent filings
? Develops technical solutions to complex design problems which require the regular use of ingenuity and creativity
? Guide the successful completion of major design efforts by ensuring technical objectives are met
? Document, follow, own, and improve the organizations design engineering processes. This role also calls for defining and capturing design engineering metrics
? Write standards and develop design solutions to aid manufacturing processes, assist with resolving supplier problems that affect cost, delivery, or performance
? Research and analyze data, such as customer design proposals, specifications, and manuals to determine feasibility of design or application
? Participate in the development and fabrication of test control apparatus and equipment, and development of methods and procedures for testing products or systems
? Implement design modifications to eliminate component or system malfunctions
? Analyze product design data to determine conformance to established design selection criteria, use of standardized parts and equipment, and design-to-cost- ratio
? Recommend modifications based on producibility, cost, and component technology factors
? Coordinate testing of new parts and equipment, evaluate test results, and approve or reject usage of parts and equipment based on test results. Evaluate initial selection of vendors
? Evaluate and approve design changes and drawing releases
? Evaluate product design for conformance to engineering principles, customer requirements, quality standards, and specifications
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Mechanical Engineer
SKILLS / APTITUDES:
? Ability to lead Mechanical Engineering
? Strong knowledge of QSR and Design Control
? Demonstrate an in-depth understanding of engineering principles, theories, and techniques associated with medical device
? Must be energetic, independent and self-motivated
? Must possess strong interpersonal, organizational and teamwork skills
? Must be proficient with Solidworks, MS Office Suite and MS Project
REQUIRED EDUCATION / EXPERIENCE:
? BS or MS in Mechanical Engineering. Minimum of 8 years of experience in designing mechanical assemblies
? 5 years minimum of Medical Device experience, including the successful development and launch of at least one medical device, from concept to completion
? Experience in product development, staffing plans and technology development activities
? Experience in developing electromechanical devices delivering airflow required

Location:	Irvine, CA United States