Director of Mechanical Engineering

We are seeking a Director of Mechanical Engineering to lead the design, development, and integration of mechanical systems for our next-generation ventilators and respiratory devices. This role requires an expert-level proficiency in SolidWorks, a deep understanding of valve design, pneumatic system integration, and fluid dynamics, and experience in medical device development. The ideal candidate will drive innovation, regulatory compliance, and engineering excellence, ensuring our ventilators meet the highest performance and safety standards. 

Key Responsibilities: 

Mechanical System Design & Product Development: 

• Lead the mechanical design and optimization of CorVent Medical’s ventilators, focusing on valves, actuators, air delivery systems, and pneumatic integration. 

• Develop advanced 3D models and assemblies in SolidWorks, ensuring precise engineering and manufacturability. 

• Transfer of industrial models to molded parts. 

• Oversee fluid flow modeling, thermal analysis, and pressure regulation for ventilatory support devices. 

• Collaborate with cross-functional teams (electrical, software, regulatory, manufacturing) to ensure seamless system integration and performance optimization. 

• Implement DFM (Design for Manufacturability) and DFA (Design for Assembly) principles to streamline production and improve cost efficiency. 

Technical Expertise & Innovation: 

• Provide technical leadership in the design and testing of high-precision mechanical ventilator components, including valve technology, turbines, mold design, and pneumatic design. 

• Conduct finite element analysis (FEA) and computational fluid dynamics (CFD) to validate designs and optimize airflow control. 

• Identify and integrate new materials, rapid prototyping methods, and innovative mechanical architectures to enhance product reliability. 

• Work closely with suppliers and manufacturing teams to ensure quality and scalability of mechanical components. 

Regulatory & Quality Compliance: 

• Ensure all designs comply with ISO 13485, FDA 21 CFR Part 820, IEC 60601, and other relevant medical device regulations. 

• Collaborate with regulatory and quality teams to support risk management (ISO 14971), verification & validation (V&V), and design history files (DHF). 

• Develop and document mechanical and pneumatic design engineering protocols, validation test plans, and risk assessments. 

Leadership & Team Development: 

• Lead, mentor, and grow a team of mechanical engineers, fostering innovation, technical excellence, and professional development. 

• Establish best practices in mechanical design, prototyping, and system testing. 

• Drive project management initiatives, ensuring timely execution and cross-functional alignment. 

Qualifications & Skills: 

Required: 

• Bachelor’s or Master’s degree in Mechanical Engineering or a related field. 

• 10+ years of experience in mechanical engineering, with at least 5 years in a leadership role within the medical device industry. 

• Expert proficiency in SolidWorks, including complex 3D modeling, assemblies, and simulations. 

• Extensive experience with valve design, pneumatic systems, and fluid dynamics for mechanical ventilators or similar medical technologies. 

• Strong understanding of ISO 13485, FDA 21 CFR Part 820, IEC 60601, and risk management (ISO 14971). 

• Knowledge of FEA, CFD, and tolerance stack-up analysis for high-precision components. 

• Proven ability to lead teams, manage projects, and collaborate cross-functionally. 

• Strong problem-solving skills and ability to drive innovative engineering solutions. 

• Demonstrated awareness of both current and developing technologies. 

• Must have strong analytical, problem solving, communication, and interpersonal skills 

• Must have excellent writing skill regarding plans and protocols. 

Preferred: 

• Experience in high-reliability respiratory devices, air handling systems, or ventilatory support systems. 

• Familiarity with GD&T (Geometric Dimensioning and Tolerancing) for precision mechanical components. 

• Experience with additive manufacturing and advanced materials selection for medical applications. 

• Knowledge of electromechanical system integration for ventilator control systems. 

• Training in ISO 13485:2016, Medical Device Directives (MDD’s) 93/42/EEC, applicable Regulation (EU) 2017/745 Medical Device Regulations and FDA Quality System Regulations (QSR) 21 CFR 820 as applicable for job function 

Why Join CorVent Medical? 

• Be part of a team shaping the future of mechanical ventilation and life-saving respiratory technologies. 

• Work in an innovative, fast-paced, and mission-driven environment.