What are the responsibilities and job description for the Manufacturing Engineer position at Intellectt Inc?
Job Title: Manufacturing Engineer
Location : Minnesota, United States
Position Summary:
We are seeking a skilled and detail-oriented Manufacturing Engineer with expertise in medical device production to join our team. This role is crucial in ensuring the design, implementation, and optimization of manufacturing processes for high-quality medical devices. The candidate will have a strong understanding of regulatory requirements, lean manufacturing principles, and a commitment to delivering innovative solutions to enhance efficiency and quality.
Key Responsibilities:
- Design and optimize manufacturing processes for medical devices, ensuring compliance with quality standards and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
- Develop and document standard operating procedures (SOPs) and work instructions.
- Identify and implement process improvements to increase efficiency, reduce waste, and enhance product quality.
- Specify, procure, and validate manufacturing equipment and tooling.
- Develop maintenance plans to ensure equipment reliability and uptime.
- Troubleshoot and resolve equipment issues promptly.
- Collaborate with the Quality team to ensure processes meet regulatory and quality standards.
- Conduct root cause analyses and corrective actions for process-related defects.
- Participate in risk management activities, including FMEA (Failure Mode and Effects Analysis).
- Work closely with R&D, Quality, and Production teams to transition products from development to manufacturing.
- Provide technical support for production teams, including training and troubleshooting.
- Act as a liaison between manufacturing and other departments to ensure seamless operations.
- Maintain accurate and thorough documentation for manufacturing processes, validations, and quality control.
- Generate reports and metrics to track production performance and identify areas for improvement.
- Ensure compliance with environmental, health, and safety regulations in all manufacturing operations.
- Promote a culture of safety and continuous improvement within the manufacturing team.
Qualifications and Skills:
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, or a related field.
- 3 years of experience in manufacturing engineering, preferably in the medical device industry.
- Strong knowledge of regulatory requirements (ISO 13485, FDA, GMP).
- Proficiency in CAD software and manufacturing tools (e.g., SolidWorks, AutoCAD, Minitab).
- Experience with lean manufacturing, Six Sigma, or other process improvement methodologies.
- Strong problem-solving and analytical skills.
- Excellent communication and collaboration abilities.
Preferred Skills:
- Certification in Six Sigma or Lean Manufacturing.
- Experience with automation and advanced manufacturing technologies.
- Knowledge of sterilization processes and materials used in medical devices.
