Senior Mechanical Engineer
VERO BIOTECH INC
Summary
The Senior Mechanical Engineer position is responsible for the mechanical engineering activities associated with the development of medical devices manufactured by Vero Biotech. The Mechanical Engineer will design and develop next-generation medical devices. The engineer will be responsible for developing, writing and executing test protocols, reports, specifications, procedures, and evaluations following FDA and other applicable medical device and combination product guidelines and standards.
Job description
Essential Duties and Responsibilities
- Lead mechanical design and development of electromechanical medical devices in accordance with Design Control and Quality Management System procedures.
- Drive late-stage product development, including prototype refinement, system integration, design verification, design freeze, and transfer to manufacturing.
- Create and maintain SolidWorks models, assemblies, drawings, bills of materials, specifications, and component requirements.
- Design and evaluate molded, stamped, machined, sheet metal, fluidic, enclosure, etc.
- Build, integrate, test, modify, and troubleshoot prototypes, fixtures, and systems.
- Integrate and evaluate pumps, valves, heaters, pressure sensors, flow sensors, gas sensors, tubing, and related hardware.
- Develop and execute mechanical, fluidic, thermal, environmental, and reliability testing.
- Perform root cause investigations and implement design improvements based on test and production results.
- Optimize designs for manufacturability, assembly, reliability, cost, and serviceability. Support tooling, pilot builds, production launch, and manufacturing issue resolution.
- Lead or support design reviews, FMEAs, risk assessments, supplier activities, and technical documentation.
- Collaborate with systems, software, firmware, electrical, test, quality, manufacturing, and external development teams.
- Use basic Python, Excel, or similar tools for engineering analysis, data evaluation, characterization, and test support.
Qualifications
- Bachelor’s degree in Mechanical Engineering or a related discipline required; master’s degree preferred.
- (7) or more years of relevant mechanical design and development experience.
- Demonstrated hands-on experience building, integrating, testing, and troubleshooting electromechanical products.
- Strong knowledge of molded thermoplastics, machined and stamped components, sheet metal, fasteners, seals, joining methods, and mechanisms.
- Proficiency with CAD software required; SolidWorks strongly preferred.
- Experience with fluidic systems and components such as pumps, valves, regulators, tubing, filters, and flow restrictions preferred.
- Experience integrating embedded hardware, sensors, heaters, motors, and other electromechanical components.
- Knowledge of engineering drawings, GD&T, tolerance analysis, Design for Manufacturing and Assembly, and design transfer.
- Experience with mechanical, fluidic, thermal, or reliability testing, data analysis, and root cause investigation.
- Familiarity with medical device Design Controls, risk management, FMEA, and Quality Management Systems.
- Basic Python scripting experience preferred.
- Strong communication, collaboration, technical leadership, vendor management, and problem-solving skills.
- Able to work hands-on and independently in a fast-paced development environment while meeting defined milestones.
Supervisory Responsibilities
- May supervise engineers, technicians, vendors, consultants, and temporary personnel.
- May train other engineers or interns.
Requirements
- Bachelor’s degree in Mechanical Engineering or a related discipline required
- Master’s degree preferred
- 7 or more years of relevant mechanical design and development experience
- Demonstrated hands-on experience building, integrating, testing, and troubleshooting electromechanical products
- Strong knowledge of molded thermoplastics, machined and stamped components, sheet metal, fasteners, seals, joining methods, and mechanisms
- Proficiency with CAD software required; SolidWorks strongly preferred
- Experience with fluidic systems and components such as pumps, valves, regulators, tubing, filters, and flow restrictions preferred
- Experience integrating embedded hardware, sensors, heaters, motors, and other electromechanical components
- Knowledge of engineering drawings, GD&T, tolerance analysis, Design for Manufacturing and Assembly, and design transfer
- Experience with mechanical, fluidic, thermal, or reliability testing, data analysis, and root cause investigation
- Familiarity with medical device Design Controls, risk management, FMEA, and Quality Management Systems
- Basic Python scripting experience preferred
- Strong communication, collaboration, technical leadership, vendor management, and problem-solving skills
- Able to work hands-on and independently in a fast-paced development environment while meeting defined milestones
Company overview
VERO Biotech Inc. is an emerging biotechnology company headquartered in Atlanta, Georgia, specializing in the design, development, and commercialization of next-generation inhaled nitric oxide (NO) delivery systems. The company focuses on addressing unmet medical needs for patients with cardiopulmonary conditions through innovative technologies that transform the delivery of inhaled nitric oxide therapy. VERO Biotech's mission centers on improving patient lives by advancing inhaled NO delivery technologies for acute care hospital settings and beyond, wherever nitric oxide treatment is required. The company's flagship product, the Genosyl Delivery System, offers a simplified, tankless solution designed to enhance the efficiency of patient care. With a workforce of 201-500 employees, VERO Biotech operates from its Technology Enterprise Park facility in Atlanta, which houses research and development, manufacturing, and quality functions. The company has demonstrated significant growth, raising $30 million in its latest funding round and maintaining a strong presence in the respiratory care community through partnerships and sponsorships with organizations like AARC and the Neonatal Heart Society.