Manufacturing Engineer I

Manufacturing Engineer I

The Manufacturing Engineer I supports daily manufacturing operations by troubleshooting production issues, monitoring yield metrics, investigating scrap and defects, and driving continuous improvement initiatives. They will additionally support implementing new equipment and processes using the IQ/OQ/PQ framework. The engineer will work closely with cross-functional teams such as Quality, Production, and R&D at multiple levels to ensure compliant and efficient manufacturing processes. The engineer will independently perform root cause analysis using tools such as 6M and 5 Why and effectively communicate findings to management.

Key Responsibilities:

• Troubleshoot manufacturing and equipment-related issues.
• Monitor and analyze yield, scrap, and defect data.
• Drive continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure smooth operations.
• Implement and validate new equipment and processes (IQ/OQ/PQ).
• Document findings and maintain compliance with FDA/ISO standards.
• Communicate and present status of activities and findings to multiple levels and audiences.

Must Have:

• Excellent or native English language fluency due to all meetings, procedures, and technical communications being in English
• Evidence of interpersonal, communication, and influence skills with multiple levels of cross functional groups

Required Experience:

0–3 years of relevant experience

Top 5 Key Skills:

• Technical problem-solving
• Data analysis (yield, scrap, process metrics)
• Strong communication skills
• Attention to detail in regulated environments
• Root cause analysis

Preferred Experience:

• Internship or co-op in regulated manufacturing (medical devices/pharma)
• Exposure to Lean Manufacturing or Six Sigma
• Experience with statistical tools (e.g., Minitab, JMP)
• Familiarity with ERP or MES systems
• Hands-on experience with equipment installation or automation

Education:

• Bachelor's degree in Mechanical Engineering (preferred), Industrial Engineering, Electrical Engineering, Chemical Engineering, or Bioengineering