Manufacturing Engineer - Intellectt INC

Position Overview:
We are seeking a skilled Manufacturing Engineer to join our team in the medical device industry. The role involves developing, improving, and maintaining manufacturing processes to ensure the efficient production of high-quality medical devices. The ideal candidate will collaborate with cross-functional teams to drive process improvements, ensure regulatory compliance, and support production goals.

Key Responsibilities:

• Design, develop, and optimize manufacturing processes to enhance product quality and efficiency.
• Evaluate and troubleshoot production processes and equipment to resolve technical issues.
• Perform process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain manufacturing documentation, including work instructions, process flow diagrams, and standard operating procedures (SOPs).
• Collaborate with cross-functional teams to ensure new product designs are manufacturable and meet quality standards.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for process and quality issues.
• Participate in continuous improvement initiatives, including Lean Manufacturing, Six Sigma, and Kaizen events.
• Support the introduction and validation of new equipment and technologies to the production floor.
• Ensure compliance with FDA regulations, ISO 13485 standards, and other applicable quality system requirements.
• Monitor and analyze production data to identify trends, improve processes, and reduce waste.
• Train production staff on new processes and equipment to ensure proper implementation.
• Work closely with suppliers to improve material quality and resolve supply chain issues.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field (Master's degree preferred).
• 2+ years of experience in a manufacturing engineering role within the medical device industry.
• Strong understanding of FDA and ISO 13485 regulatory requirements.
• Experience with process validation (IQ, OQ, PQ) and equipment qualification.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and statistical analysis tools (e.g., Minitab).
• Familiarity with Lean Manufacturing and Six Sigma methodologies (certification is a plus).
• Excellent problem-solving skills and the ability to work collaboratively in a team environment.
• Strong organizational skills and attention to detail.

Preferred Skills:

• Hands-on experience with medical device assembly processes and automation.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Familiarity with ERP systems and production planning tools.

Work Environment:
This position involves working in a combination of office and manufacturing environments, with occasional travel to supplier locations or other company facilities.