Manufacturing Engineer

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
).

• 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.

• 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 (Solid Works, 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.

• Targeted Placement: Direct marketing to our network of hiring managers in the Life Sciences and Med Tech industries.
• Resume Rebuild: Optimization of your profile to highlight engineering technicalities alongside GxP documentation skills.
• Interview
  
  Coaching:
  
  Guidance on technical case studies and regulatory compliance scenarios.

Email your updated resume to: