Job SiteMills River, NC (USA)
Area of ResponsibilityProduction / Engineering
Type of EmploymentPermanent Position
The position of Manufacturing Engineer is responsible for supporting manufacturing by developing, qualifying, implementing and maintaining manufacturing equipment, processes and procedures.
- Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ).
- Define and document equipment & process requirements.
- Develop/improve and maintain specifications and procedures for manufacturing, test and inspection processes, tooling and equipment.
- Develop and execute test protocols (e.g., validation protocols), author test reports, technical memos, investigations and document changes in accordance with regulatory and corporate requirements.
- Perform risk assessments.
- Perform root cause analysis. Develop and implement corrective actions.
- Support existing manufacturing product line(s).
- Responsible for the production line efficiency improvements (processes, layouts, fixtures/tooling, etc.). Utilize Lean tools to eliminate waste, increase capacity, and drive cost out of the process
- Trouble-shoot processes, designs, equipment and quality systems.
- Participate in product, design and/or technology transfers. Concurrently develop assembly and testing methods.
- Serve as technical expert for existing products/processes as well as product transfers. Will be the primary technical interface to the design division regarding design for manufacturing and service.
- Participate in design reviews representing manufacturing and service as required
- Responsible for the identification, planning and execution of cost improvement projects.
- Maintains working knowledge of company policies and procedures, ISO and FDA requirements.
- Bachelor’s degree in an engineering discipline.
- Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies
- Experience in process and equipment validations for medical product assembly.
- 5+ years’ experience in a manufacturing environment in a regulated industry, medical device preferred.
- Experience with hands-on electro-mechanical, manual assembly and troubleshooting.
- Ability to read and understand mechanical drawings and electrical schematics.
- Demonstrated ability to gather, analyze and evaluate data as well as recommend actions.
- Computer skills: Word, Excel, PowerPoint
- PFMEA/Risk analysis.
- Fixture design experience.
- Excellent verbal and written communication skills.
- Time management and organizational skills.
- Demonstrated problem solver & team player.
- Experience with drafting/CAD/3D modeling.
RAUMEDIC is an EQUAL OPPORTUNITY EMPLOYER
So that your application can be processed faster by us, please apply here online under "Apply now". We look forward to receiving your application. For reasons of environmental protection and cost, RAUMEDIC expressly waives paper applications or application folders.