Job Description

Job Title: Manufacturing Engineer

About the Role

Our client, a leading medical device manufacturer, is seeking an experienced Manufacturing Engineer to support production operations, process optimization, and product quality improvement. The role involves collaborating with cross-functional teams to ensure compliant, efficient, and cost-effective manufacturing processes in alignment with FDA and ISO 13485 standards.

Key Responsibilities

• Develop, implement, and optimize manufacturing processes for medical devices, ensuring product quality, reliability, and regulatory compliance.
• Support process validation (IQ/OQ/PQ) and equipment qualification activities in accordance with cGMP and FDA requirements.
• Lead root cause investigations and implement effective CAPA (Corrective and Preventive Actions) to prevent reoccurrence.
• Partner with design and R&D teams for new product introduction (NPI) and seamless design transfer to manufacturing.
• Prepare and maintain process documentation - including work instructions, process flow diagrams, PFMEA, and control plans.
• Apply Lean Manufacturing and Six Sigma principles to eliminate waste, reduce cycle times, and improve efficiency.
• Support the selection, installation, and validation of production equipment and tooling.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory requirements.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering.
• 4+ years of experience as a Manufacturing Engineer within the medical device or life sciences industry.
• Strong knowledge of process validation, risk management (ISO 14971), and documentation practices.
• Hands-on experience with electromechanical assemblies, plastic components, or cleanroom manufacturing.
• Proficient in SolidWorks, AutoCAD, and familiar with ERP/MRP systems.
• Excellent problem-solving, analytical, and cross-functional communication skills.
• Green Belt or exposure to Lean/Six Sigma methodologies preferred.

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