Manufacturing Process Engineer
Location
Chicago, IL
Level
Mid-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-09-15
Responsibilities
- Act as the lead technical expert for all manufacturing processes across platforms.
- Train and mentor technicians, ensuring effective knowledge transfer.
- Own and manage the Master Validation Plan and other key validation documents.
- Create, revise, and control detailed build instructions and standard operating procedures.
- Drive production yield improvements and cost reductions through data-driven analysis.
- Serve as the bridge between product development and manufacturing for new product introductions.
- Monitor process metrics and generate reports to inform operational decision-making.
Job Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or 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 cross-functional collaboration skills.
- Preferred certifications such as Six Sigma Green Belt or Certified Manufacturing Engineer.
