Manufacturing Engineer

Our client, the recognized world technology leader in their niche medical device industry is seeking a Manufacturing Engineer to join their successful team.

Responsibilities will include:

• Provide hands-on support to manufacturing, including troubleshooting, implementing manufacturability improvements, training on new products or processes, documentation compliance, and general process improvements.
• Develop, validate, document, and release manufacturing and testing processes to support new product implementation or existing products.
• Analyze processes and process data to identify opportunities to improve the reliability or efficiency of operations and/or to reduce cost.
• Create and maintain Manufacturing Procedures (MPs), Test Procedures (TPs), Calibration Procedures (CPs), and Quality Control Instructions (QCIs) that ensure products are of high quality and meet customer requirements.
• Perform tests to verify and validate new products, processes, software, materials, or vendors, as required, and document the results in Technical Documents (TD).
• Generate and execute equipment validation plans (IQ/OQ/PQ).
• Initiate and process Engineering Change Orders (ECO) and Temporary Change Orders (TCO) per established procedure.
• Participate in Material Review Board (MRB) meetings and lead root cause analysis and corrective actions for non-conforming components.
• Work with Suppliers and Company’s internal manufacturing to implement sustaining and cost reduction activities.
• Adhere to established procedures under our client’s Quality System.

Background profile:

• B.S. in Engineering, Mechanical or Electrical Engineering is preferred.
• 5+ years of experience in medical device manufacturing.
• Experience working in high-volume manufacturing industry. Consumer electronics manufacturing experience is a plus.
• Proficient with dimensional inspection and test equipment.
• Lean manufacturing experience is a plus.
• Prior experience in a regulated environment is a plus.
• Excellent organizational, record keeping, and communication skills (verbal and written).

Tagged as: consumer, electronics, LEAN, medical device, MRB, validation