Sr. Manufacturing Engineer

We are seeking an experienced Senior Manufacturing Engineer to support a product transfer project within a regulated medical device manufacturing environment. The ideal candidate will have strong experience in manufacturing engineering, process validation, technical documentation, and engineering support while working independently with minimal supervision.

This role requires a proactive engineering professional capable of leading complex technical activities, identifying manufacturing challenges, recommending effective solutions, and supporting successful product transfer initiatives.

• Lead manufacturing engineering activities supporting product transfer projects.
  
• Plan, execute, and support equipment and process validation activities, including:
  
  • Installation Qualification (IQ)
    
  • Operational Qualification (OQ)
    
  • Performance Qualification (PQ)
    
• Generate technical reports, validation protocols, and engineering documentation.
  
• Analyze manufacturing processes and recommend improvements to optimize quality, efficiency, and reliability.
  
• Lead complex engineering assignments involving multiple cross-functional teams.
  
• Identify technical issues proactively and develop practical solutions with minimal supervision.
  
• Evaluate manufacturing processes and implement improvements where required.
  
• Collaborate with Quality, Operations, Validation, and other engineering disciplines to ensure project success.
  
• Participate in peer reviews of engineering work, validation activities, and technical documentation.
  
• Ensure compliance with applicable quality systems and engineering standards.
  

Requirements

• Bachelor's Degree in Mechanical, Electrical, Software, Manufacturing, or related Engineering discipline.
  
• Minimum 5 years of Manufacturing Engineering experience.
  
• Hands-on experience executing IQ, OQ, and PQ validations.
  
• Experience supporting product transfer projects (preferred).
  
• Experience generating technical reports and engineering documentation.
  
• Ability to work independently with minimal supervision.
  
• Strong written and conversational English communication skills.
  
• Excellent analytical, troubleshooting, and problem-solving skills.
  
• Strong organizational and project management abilities.
  

• Medical device or other regulated manufacturing industry.
  
• Product transfer or new product introduction (NPI).
  
• Manufacturing process optimization.
  
• Cross-functional project leadership.
  
• Technical documentation and validation lifecycle support.
  

• Manufacturing Engineering
  
• Product Transfer
  
• Process Validation (IQ/OQ/PQ)
  
• Technical Report Writing
  
• Engineering Documentation
  
• Manufacturing Process Improvement
  
• Root Cause Analysis
  
• Cross-Functional Collaboration
  
• Technical Leadership
  
• Project Coordination
  
• Problem Solving
  
• English (Written & Verbal)