Manufacturing Process Engineer
Location
Chicago, IL
Level
Mid-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-10-30
Responsibilities
- Act as the lead technical expert for all manufacturing processes across platforms.
- Train and mentor technicians to ensure effective knowledge transfer.
- Own and manage the Master Validation Plan and other key validation documents.
- Create and control detailed build instructions and standard operating procedures (SOPs).
- Collaborate with R&D and test engineering teams for design optimization.
- Drive production yield improvements through data-driven root cause analysis.
- Oversee equipment specification, procurement, installation, and validation.
Job Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field.
- 2–5 years of hands-on experience in a regulated manufacturing environment.
- Strong understanding of validation methodologies and quality systems (ISO 13485, FDA QSR).
- Experience with Lean/Six Sigma and root cause methodologies.
- Proficiency with CAD, Minitab/JMP, MES, and ERP systems is a plus.
- Excellent communication and collaboration skills.
- Preferred certifications include Six Sigma Green Belt or Black Belt, and Certified Manufacturing Engineer (CMfgE).
