We are looking for aSenior Manufacturing Engineer to join our NTI and Equipment Development Team. This team is responsible for:
- Designing novel equipment used to manufacture medical devices
- Implementing equipment into production.
- Design electro-mechanical fixtures and tooling in Solidworks
- Assemble and test prototypes
- Prepare equipment drawings and documentation
- Create and execute equipment qualification protocols.
- 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).
- 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.
- 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