Mechanical Systems Engineer

Job Description:

Perform engineering duties in planning and designing tools, engines, machines, and other mechanically functioning equipment. Contributes to the design of custom production processing equipment used in the cGMP creation, processing, and delivery of radioisotopes. As part of the Isotope Production Equipment Engineering Development team, contributes to design and development activities focused on identifying, developing, and implementing mechanical solutions to support the current and future product portfolio. Effectively communicates safety and quality issues raised by customers or staff in a timely manner. Using CAD software, creates and modifies mechanical designs based on product specifications, production tooling requirements, and input from senior staff. Develops or adapts designs to meet the unique requirements of a cGMP radioactive pharmaceutical isotope production environment, including radioactive shielding. Works with a variety of vendors, particularly sheet metal, plastic, radiation shielding, machine shops, and custom fabricators to develop high quality and cost-effective sub-components and system-level production processing equipment. Comprehensively document designs, trials, and other work in detailed engineering reports. Creates and updates drawings, specifications, and BOM’s through Change Orders. Presents drawings and project progress to peers and management. Interprets detailed engineering CAD, P&ID, and system schematic drawings. Participates in process hazard reviews and modify designs as necessary to ensure safe operation and appropriate specifications are captured. Works collaboratively in cross- functional teams. Leads smaller project specific tasks. Supports the company’s Quality System and Health & Safety Program by following policies and procedures.

Position requires domestic and international travel up to 20% of the time.

Position allows for partial remote work. Must live within reasonable commuting distance. Reports to company office in Beloit, WI.

Job Requirements: Requires a Bachelor’s degree in Mechanical Engineering or related engineering field. Must have some education or hands-on experience with each of the following skills: 3D CAD Modeling and Simulation - Using 3D CAD software for designing, modeling, and simulating mechanical systems; Medical Device Risk Management - Risk management processes and tools, including Risk and Hazard Analysis, DFMEA, and PFMEA, particularly in the context of medical devices and radioactive shielding design; FDA/cGMP Compliance - Designing and developing processes for medical/pharmaceutical devices and compliance with FDA and cGMP regulations; Materials Engineering - Metal and plastic materials, their properties, and appropriate applications in mechanical design; Mathematical Modeling and Analysis - Utilizing mathematical models and simulations to optimize mechanical system performance, including structural, thermal, and fluid flow analysis; Manufacturing Processes - Various manufacturing processes such as machining, injection molding, and sheet metal fabrication; and Interpreting Technical Documentation - Interpreting and analyzing technical drawings, specifications, and documentation to ensure accurate implementation and compliance.NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

To apply, send resume to: careers@northstarnm.com

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