Senior Mechanical Engineer

About Telesair: Telesair Inc. is an Irvine, California based medical device startup. The company develops respiratory care devices for treating both acute and chronic pulmonary disease. It is focused on bringing innovative solutions to improve patient safety and quality of care, and to reduce the burden of care for caregivers. *Telesair Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Senior or Principal Mechanical Engineer Responsibilities: Project support includes overall design, mechanical requirement development, design for manufacturing, test method development, and product verification and validation testing Supports engineering by researching, designing, developing, and testing according to established policies, procedures, government and compliance regulations, and customer requirements Builds prototypes and works to help develop test fixtures Performs failure analysis, verification testing and generation of test reports for modules or subsystems Develop SolidWorks models, drawings and assemblies Debug via root cause analysis Develop and update engineering documents such as instructions, drawings, test procedures, and reports Complete documentation of design efforts for the Design History File Investigate new tooling, materials, manufacturing processes, and technologies Research and qualify new suppliers and vendors Support quality, manufacturing, and regulatory to bring to market effective and safe products. Encouraged to assist in the writing of reports, work instructions, test methods and procedures Support the design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs Qualifications: Minimum of 3 - 5 years of experience in medical device industry (ISO 13485 regulated environment) Bachelor''s degree or advanced degree in Mechanical Engineering (or other engineering discipline) with proven track record for mechanical and technical aptitude Proficiency with CAD modeling and drafting (i.e., SolidWorks or equivalent) with heavy emphasis on design engineering. CSWP/CSWE is a huge plus. Experience in understanding of quality systems, design controls, and manufacturing processes Ability to understand, analyze and troubleshoot complex systems Ability to develop innovative solutions to complex problems Ability to work hands-on to create prototypes High level of proficiency in engineering and scientific principles Self-starter and driver - able to execute effectively Must be able to work and execute with little or no guidance Must possess strong communication acuity, written and verbal Ability to solve complex problems Preferred Familiarity with IEC 60601 design and testing Knowledge and experience in product development processes Knowledge in electro-mechanical design Experience with statistical analysis and design of experiments (DOE) Experience in respiratory health devices is a huge plus Experience in oxygen generation methodologies and applications is a huge plus Language Skills: Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 50 lbs. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.

Created: 2025-11-15