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.

• 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.

Competencies

• Problem Solving – Draws sound conclusions based on the facts and identifies the root cause of problems. Creatively solves problems using good engineering practices. Makes timely, informed decisions that consider the goals, constraints, and risks of situations.
• Project Planning and Execution – Focuses on desired outcomes and how best to achieve them. Uses sound methods to plan and track projects. Takes personal responsibility for the quality and timeliness of work. Looks for opportunities to expedite project deliverables.
• Collaboration – Supports organization goals and values. Builds constructive working relationships in a productive team environment. Resolves interpersonal and situational conflicts diplomatically. Works on large and small projects across departmental and site boundaries.
• Computer Skills-To perform this job successfully, an individual must have the ability to design products in 2D and 3D CAD programs. Should also have a working knowledge of Microsoft Excel, Word, PowerPoint, and Outlook.
• Communication Skills -The ability to communicate effectively both in writing and verbally with all levels of supervision on the status of jobs.
• Tactfully professionalism-approaches others; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Safety and Security-Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Analytical-Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Problem Solving-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.
• Change Management-Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; 
• Quality Management-Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

Physical Demands and Work Environment

• Standard office and business environment.