Mechanical Engineer

Summary of Position

The Mechanical Engineer will be a key member of a design team responsible for creating, engineering, construction and maintenance of manufacturing and quality control equipment used for the manufacturing of radioisotopes used in radiopharmaceutical drug products for PET and SPECT imaging at hospitals and other related health care facilities.

Schedule:Monday - Friday – 6:00 am to 2:30 pm 

Essential Functions

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).  
• As part of a design team, the position will be responsible for creating, engineering and constructing manufacturing equipment used in the production of radioisotope products.
• Participates in the development of workflow optimization, equipment design, construction and the automation of production and quality control processes.  
• Contributes to the selection and/or fabrication of components sourced from outside vendors and machine tool companies.
• Establishes user requirements, design specifications and participates in the design, construction and qualifications for each project.
• Works closely with a team of Cyclotron Engineers, CMC Chemists and Production Technicians to design, install, commission and qualify manufacturing equipment, while ensuring compliance with cGMP and other regulatory requirements.
• Overseeing and participating in the maintenance, troubleshooting, and repair of cyclotron systems, including mechanical, electrical, vacuum components and He leak testing equipment.
• Developing and implementing effective preventive maintenance programs to minimize downtime, ensure optimal cyclotron performance and Manual writing.
• Diagnosing complex cyclotron issues, conducting root cause analysis, and implementing corrective actions.
• Designing mechanical components using computer aided drafting (CAD) software such as Autodesk AutoCAD or Autodesk Inventor.

Requirements

• Bachelor degree in mechanical engineering technology or a related field is required.
• Three or more years of relevant experience in an industrial manufacturing environment required.
• Requires experience in mechanical design and project management of moderate complexity with minimal oversight.
• Requires familiarity with advanced materials and fabrication methods.  
• Must have a familiarity with vacuum systems and leak testing of systems.
• Requires experience in designing and prototyping equipment using CAD software; AutoCAD, Inventor Pro experience is preferred.  
• Requires practical building/fabrication experience.
• Prior experience working with a Quality Management System is preferred.
• Familiarity with current metalworking methods including Milling, Lathe, Drilling, Brazing and Soldering and sheet metal fabrication.
• Prior experience with design of industrial electromechanical equipment, such as electromagnets, vacuum and RF systems, high temperature equipment, radiopharmaceutical equipment including radiation shielding, accelerator and target design, would be an added plus.
• Requires excellent organization, computer/PC and communication skills including technical writing skills with experience describing chemical and/or mechanical processes, along with documenting design change and design controls. 

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.  
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.  
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.