Senior Manufacturing Engineer
We are looking for a Senior Manufacturing Engineer to join our NTI and Equipment Development Team.This team is responsible for: Designing novel equipment used to manufacture medical devicesImplementing equipment into production. You will: Design electro-mechanical fixtures and tooling in SolidworksAssemble and test prototypesPrepare equipment drawings and documentationCreate and execute equipment qualification protocols. This work will support the equipment installation and ramp up at a new production facility. You'll work closely with mechanical, manufacturing, and quality engineers at two manufacturing sites to implement new equipment and technologies into production. As part of a team building a new line to expand our capacity to produce world-class medical devices, you will spec and procure equipment, create equipment acceptance protocols, and execute equipment qualifications. The ideal candidate will bring a wealth of experience in the design of tooling and automated equipment, project management, and equipment testing & qualification. This role provides an exciting opportunity to design novel equipment while helping to create life-saving products! What You'll Do: Own the design and development of fixtures and equipment, in Solidworks, for testing and manufacturing of medical devices. Design and document robust equipment and processes capable of a high level of quality. Write design specifications and equipment qualification protocols, particularly for hardware and software that transmits data. Execute equipment qualifications of new equipment. Collaborate with other engineers in the start-up and commissioning effort for manufacturing equipment and processes at a new production site. Develop and manage project plans for automated equipment solutions. Work with internal and external vendors to develop equipment and processes. Develop and troubleshoot automated equipment (PLCs, robotics, RFIDs, etc). Required: BS required in Mechanical Engineering or related field. 5+ years of experience in manufacturing equipment design, build, and commissioning. Medical Device industry or other regulated industry Creating models and fabrication drawings of assemblies and machined components in Solidworks Familiarity with Design For Manufacturability, particularly as it applies to machined components. Strong Project Management skills. Experience: Specifying tolerances and conducting tolerance analysis in assemblies. Fasteners, 3D printing, and assembling prototypes. Leading cross-functional project teams. Testing equipment and writing equipment documentation (acceptance testing protocols, maintenance procedures, qualification procedures). Familiarity with PLC hardware selection, programming, troubleshooting, and configuration for automated systems. Designing electrical controls systems, specifying electrical components, and designing the mechanical layout of an electromechanical controls system is an asset