Senior Mechanical Engineer

Position 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.

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.