Qualifications

• 5-7 years of Manufacturing Engineering experience with a focus on leadership
• Proven track record in New Product Introduction (NPI) initiatives
• Expertise in process validation and equipment qualification procedures
• Strong understanding of FDA QSR and ISO 13485 regulatory standards
• Experience in manufacturing process development and optimization techniques
• Background in automation and capital equipment projects
• Technical aptitude for root-cause analysis and problem-solving, especially in regulated environments

Responsibilities

• Lead the validation of processes and qualifications of equipment in manufacturing operations
• Support the development and introduction of new products into the manufacturing line
• Develop and optimize processes and layouts for production efficiency
• Collaborate with cross-functional teams including Operations, Quality, R&D, and Regulatory
• Ensure compliance with relevant manufacturing and quality standards
• Troubleshoot and resolve process-related issues and implement corrective actions
• Analyze key manufacturing metrics to enhance production performance and efficiency

Benefits

• Mentorship opportunities for career growth within the organization
• Impactful role that directly contributes to product innovation and efficiency
• Collaborative work environment with cross-functional teams
• Involvement in cutting-edge projects and technology transfers
• Opportunity to lead and influence manufacturing practices in a highly regulated industry