Manufacturing Engineer

About the Role

We are seeking a motivated Manufacturing Engineer to design, optimize, and scale production processes within the medical device and pharmaceutical sectors. In this role, you will bridge the gap between product design and large-scale manufacturing, ensuring that life-saving products are built with precision, efficiency, and strict adherence to regulatory standards (such as ISO 13485 and cGMP).

Key Responsibilities

• Process Optimization: Design and implement lean manufacturing workflows to improve throughput, reduce cycle times, and eliminate waste using DMAIC methodologies.
• Equipment Validation: Lead IQ/OQ/PQ (Installation, Operational, and Performance Qualification) activities for automated assembly lines and production machinery.
• Quality Engineering: Identify "Critical-to-Quality" (CTQ) parameters and perform Root Cause Analysis (RCA) on production deviations or non-conformances (NCRs).
• Systems Integration: Utilize MES (Manufacturing Execution Systems) and ERP platforms to monitor real-time production data and maintain high levels of data integrity.
• Technical Documentation: Author Standard Operating Procedures (SOPs), Work Instructions, and validation protocols to ensure compliance with GxP requirements.
• Risk Management: Conduct PFMEA (Process Failure Mode and Effects Analysis) to proactively mitigate risks in the manufacturing environment.

Qualifications

• Education: Bachelor’s or Master’s degree in Mechanical, Biomedical, Industrial, or Chemical Engineering (Required).
• Experience: 0–5 years of experience in manufacturing, process engineering, or academic research involving robotics and systems design.
• Technical Skills (Required):
• Proficiency in CAD software (SolidWorks, AutoCAD) for fixture design and floor layouts.
• Strong understanding of Lean Six Sigma or Total Quality Management (TQM).
• Familiarity with GAMP 5 frameworks for computerized system validation in manufacturing.
• Knowledge of 21 CFR Part 820 regarding Quality System Regulations for medical devices.
• Preferred Skills:
• Experience with PLC programming or automated inspection systems (Vision systems).
• Familiarity with Minitab or Python for statistical process control (SPC).
• Knowledge of cleanroom requirements and sterilization processes.