Sr. Manufacturing Engineer

Responsibilities

• Develop, optimize, and maintain manufacturing processes to improve efficiency, quality, and productivity.
• Lead manufacturing projects from concept through implementation, ensuring timely delivery and cost-effectiveness.
• Support New Product Introduction (NPI) by developing manufacturing methods, tooling, and work instructions.
• Design and implement process improvements using Lean Manufacturing and Six Sigma methodologies.
• Analyze manufacturing data to identify process improvements and reduce waste.
• Troubleshoot production issues and implement effective corrective and preventive actions (CAPA).
• Create and maintain manufacturing documentation, including SOPs, work instructions, process flow diagrams, PFMEA, and control plans.
• Support equipment selection, installation, commissioning, and qualification.
• Participate in design reviews to ensure products are manufacturable and meet quality requirements.
• Lead root cause investigations using methodologies such as 8D, 5 Whys, and Fishbone Analysis.
• Ensure compliance with GMP/cGMP, FDA, ISO 9001, ISO 13485, or other applicable industry standards.
• Mentor junior engineers and provide technical guidance to manufacturing teams.
• Support internal, customer, and regulatory audits.

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, Electrical, Chemical Engineering, or a related discipline.
• 5+ years of manufacturing engineering experience in a regulated manufacturing environment.
• Strong knowledge of manufacturing processes, process optimization, and production support.
• Experience with Lean Manufacturing, Six Sigma, Kaizen, and Continuous Improvement.
• Hands-on experience with process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation.
• Experience with CAPA, Root Cause Analysis, PFMEA, Control Plans, SPC, and GD&T.
• Proficiency with ERP/MRP systems and Microsoft Office applications.
• Excellent analytical, problem-solving, and communication skills.
• Ability to lead cross-functional projects and manage multiple priorities.