Job Title : Manufacturing Engineer
Job Description
As a Manufacturing Engineer, you will lead projects related to the transfer or development of service and manufacturing for small capital medical devices.
This role involves supporting and designing manufacturing processes, procedures, and production layouts, while ensuring compliance with regulations governing the manufacture of medical devices.
This manufacturing engineer will report to the director of engineering and be supported by 5 other manufacturing engineers as well a team of quality engineers.
As this role supports a services center for this client multiple products are coming in to be worked on and remediated. You will work on projects based teams to support the incoming work or new projects.
You will be tasked with the validations of the machines as well ensuring they are in scope with the FDA.
- Participate in and lead projects related to service and manufacturing of medical devices
- Design manufacturing processes and production layouts
- Develop and diagnose electrical testing equipment and test software
- Inspect machinery and tools to ensure efficiency and product quality
- Ensure compliance with regulations governing medical device manufacturing
- Develop and review validation documentation for manufacturing processes
- Collaborate with cross-functional teams globally to transfer processes
Hard Skills
- Bachelors Degree in Mechanical, Biomedical, or related field
- 2+ years in a project-based manufacturing environment
- Validation experience (IQ, OQ, PQ)
- Medical device experience
Work Site
This is a fully on-site position in Indianapolis, Indiana.
Work Environment
Onsite manufacturing environment. This is a service center so there is no true manufacturing but equipment is sent back to be processed and worked on.
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