Overview:
The Manufacturing Engineer will work with other personnel to design, implement and maintain manufacturing processes. The Manufacturing Engineer will be responsible for developing Process Failure Mode and Effects Analysis, Process Flow Diagrams, Manufacturing Cells and Line Layouts, Process Routers, Equipment Qualification and Process Validation Protocols, Standard Operation Procedures and Work Instructions.
Responsibilities:
• Design processes, specify equipment, develop work instructions, perform validation (IQ, OQ, PQ) and train production personnel.
• Develop, validate and implement automated, semi-automated and manual assembly and test equipment and tooling required for the production of disposable products. Ensure all equipment and tooling are properly documented and under calibration and preventative maintenance control as required.
• Participate in FMEA activities to ensure process shortcomings are identified and appropriately addressed.
• Work with Design Engineers and Quality Assurance to ensure that products are designed considering ease of manufacture and that the product will adhere to performance, cost, and quality requirements.
• Coordinate with Quality Assurance and Research and Development to maintain an approved internal Quality System that meets GMP, QSR and ISO 9001 requirements.
• Assist in pilot production of various products.
• Support production of products including ensuring operators are properly trained, production schedule is adhered to, and production paperwork is accurate. Work with production personnel to identify improvement areas.
• Continuously improve safety, quality, lead-time, productivity and cost of existing manufacturing processes.
• Identify root causes of manufacturing process nonconformities using NCMR and CAPA. Implement necessary actions to correct and prevent recurrence.
Qualifications:
• 5 to 8 years of medical device manufacturing experience.
• Knowledge of design and fabrication of electro-mechanical components and assemblies.
• Experience using SolidWorks desirable. Experience with 3-D solid modeling (e.g., SolidWorks, AutoCAD, ProEngineer) required.
• Proficient in Microsoft Office.
• Working knowledge of FDA GMP, QSR and ISO 13485 guidelines.
• Ability to function efficiently both independently and as a team member.
• Motivated individual able to work with minimal supervision.
Education:
• B.S. Degree in Mechanical Engineering or Mechanical Engineering Technology.
