Senior Mechanical Engineer

VERO BIOTECH INC•Atlanta, GA

14d•Onsite

About The Position

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.

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.
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.
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.
Ability to design products in 2D and 3D CAD programs.
Working knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.
Ability to communicate effectively both in writing and verbally with all levels of supervision on the status of jobs.
Tactful professionalism-approaches others; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
Identifies and resolves problems promptly; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem-solving situations; Uses reason even when dealing with emotional topics.
Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance.
Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

Nice To Haves

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.
Basic Python scripting experience preferred.

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.
May supervise engineers, technicians, vendors, consultants, and temporary personnel.
May train other engineers or interns.