Our client, a medical device manufacturing company, has an immediate opening for a Manufacturing Engineer. This role will work with other personnel to design, implement, and maintain manufacturing processes.

Responsibilities:

• Design processes, specify equipment. develop work instructions, perform validation (IQ, 00, 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 taking into consideration 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 the requirements of FDA QSR and ISO 13485
• Assist in pilot production of various products, developing lean manufacturing cells that optimize throughput and quality
• Support production of products including ensuring operators are properly trained, production schedule is adhered to, and that production paperwork is accurate. Work with production personnel in identifying areas for improvement
• Continuously improve safety, quality, lead-time, productivity, and cost of existing manufacturing processes
• Identify root causes of manufacturing processes nonconformities using NCMR and CAPA . Implement necessary actions to correct and prevent the recurrence of nonconformities
• Other responsibilities as required

Requirements:

• B.S. Degree in Mechanical Engineering, Mechanical Engineering Technology, Manufacturing Engineering, or similar degree
• 5 to 8 years of medical device manufacturing experience
• Experience with 3-D solid modeling (e.g. SolidWorks, AutoCad. ProEngineer)
• Medical device environment experience beneficial (ISO 13485 and FDA QSR)
• Six Sigma Black Belt beneficial
• Lean Certification beneficial
• Knowledge of design and fabrication of electromechanical components and assemblies
• Experience using SolidWorks desirable
• Proficient in Microsoft Office
• Working knowledge of FDA GMP, QSR and ISO 13485 guidelines
• Function efficiently as both a team member and independently
• A motivated individual that is able to work with minimal supervision
• Full range of motion for wrist, hand, and finger dexterity
• Sitting, working at a computer for long periods of time
• This position requires 100% on-site attendance