Senior Mechanical Engineer

Qnovia, Inc.; Newport Beach (CA); Hybrid; USD 140,000 - 180,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision insurance

Equity ownership in a pre-commercial stage company

Flexible hybrid work arrangement

401(k) with company match

Job summary

Qnovia, Inc. in Newport Beach, California, is seeking a Senior Mechanical Engineer to lead the design and development of next-generation ultrasonic nebulization devices. This role involves comprehensive responsibilities, including CAD modeling, DFM/DFA optimization, and collaboration with cross-functional teams for product readiness.

Qualified candidates should have a Bachelor's degree in Mechanical Engineering, 7+ years of experience in medical device design, and proficiency in SolidWorks. The position offers a competitive salary of $140,000 to $180,000 annually, plus equity participation and comprehensive benefits.

Qualifications

• 7+ years of experience in mechanical design of Class II or Class III medical devices.
• Strong understanding of FDA design controls (21 CFR 820) and ISO 13485.
• Experience with design verification and validation (V&V) testing.

Responsibilities

• Lead mechanical design of handheld nebulization devices.
• Develop and execute test protocols for device performance.
• Collaborate with firmware and electrical teams on integration.

Skills

Mechanical design of Class II or Class III medical devices

Proficiency in SolidWorks or equivalent 3D CAD software

GD&T knowledge

Excellent written and verbal communication skills

Education

Bachelor's degree in Mechanical Engineering or related field; Master's preferred

Tools

SolidWorks

Job description

Design and develop next-generation ultrasonic nebulization devices from concept through production, ensuring performance, reliability, and manufacturability at scale.

About the Role

Qnovia is developing a proprietary ultrasonic nebulization platform that delivers aerosolized drugs with unprecedented precision. As a Senior Mechanical Engineer, you will be instrumental in the design, prototyping, and production-readiness of our inhalation devices. You will work cross-functionally with firmware, formulation, and regulatory teams to bring novel drug delivery systems from bench to bedside.

Responsibilities

• Lead mechanical design of handheld nebulization devices, including CAD modeling, tolerance analysis, and DFM/DFA optimization
• Develop and execute test protocols for device performance, durability, and environmental qualification
• Collaborate with firmware and electrical engineering teams on electromechanical integration
• Support design transfer activities and interface with contract manufacturers
• Generate and maintain engineering documentation including design history files (DHFs), BOMs, and engineering change orders
• Contribute to risk management activities including DFMEA and design verification/validation planning
• Evaluate and select materials, components, and manufacturing processes for medical-grade applications
• Mentor junior engineers and provide technical leadership on complex design challenges

Qualifications

• Bachelor's degree in Mechanical Engineering or related field; Master's preferred
• 7+ years of experience in mechanical design of Class II or Class III medical devices
• Proficiency in SolidWorks or equivalent 3D CAD software
• Experience with GD&T, injection molding, and precision assembly processes
• Strong understanding of FDA design controls (21 CFR 820) and ISO 13485
• Experience with design verification and validation (V&V) testing
• Excellent written and verbal communication skills

Preferred Qualifications

• Experience with ultrasonic transducer systems or piezoelectric actuators
• Background in aerosol generation or respiratory drug delivery devices
• Experience with rapid prototyping (3D printing, CNC machining)
• Familiarity with IEC 60601 and ISO 14971 risk management standards

$140,000 – $180,000 annually, depending on experience. Equity participation included.

• Comprehensive medical, dental, and vision insurance
• Equity ownership in a pre-commercial stage company
• Flexible hybrid work arrangement
• 401(k) with company match

Qnovia, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact us at [e-mail].

This job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Qnovia reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.