Position Details
About this role
This role involves designing and developing manufacturing processes, tooling, and fixtures to meet production goals while ensuring quality and regulatory compliance in a healthcare manufacturing setting.
Key Responsibilities
- Design manufacturing processes
- Evaluate production equipment
- Support process validation
- Troubleshoot manufacturing issues
- Generate process documentation
Technical Overview
The technical environment includes process validation, statistical process control, and quality improvement tools such as Gage R&R, Cp, Cpk, and SPC, within a regulated healthcare manufacturing environment.
Ideal Candidate
The ideal candidate is a manufacturing engineer with at least 3 years of experience in process validation, quality systems, and healthcare manufacturing environments. They should be skilled in statistical tools like Gage R&R, Cp, Cpk, and SPC, with a strong understanding of FDA regulations and process improvement.
Must-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of Bachelor's Degree, Less than 3 years of experience, No experience with FDA regulations or process validation
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