Manufacturing Engineer - NeedleTech Products, Inc

The Manufacturing Engineer will collaborate with the manufacturing departments to identify, investigate and troubleshoot process issues.  Collaborate with product development to transfer products to manufacturing and ensure a high degree of process capability.  Conduct Process/Equipment Validation to comply with regulatory requirements. Generate necessary validation protocols, studies, with related data analysis and approvals.

Essential Job Duties:

• Support manufacturing by troubleshooting process problems in a timely manner and delivering solutions developed through individual contribution and collaboration with manufacturing, operations, quality and product development.
• Partner with the product development, quality and manufacturing team to investigate the root causes of process problems and implement corrective actions.  Design fixtures and generate (SOPs) procedures to be used in manufacturing to ensure product quality and process capability.
• Review procedures for accuracy and make updates using the internal Document Change Order system to reflect process changes.
• Work with manufacturing to develop manufacturing processes’ (SOPs) standard operating procedures, drawings, and other data acquisitions/inspections documents and forms.
• Support the implementation of GMP (Good Manufacturing Practices) throughout the manufacturing organization. Participate in the training of manufacturing supervisors, operations and assemblers. Provide mentoring and technical support for both new and existing processes.
• Collaborate with Development Engineers on new product launches.
• Lead the validation/qualification of new processes and equipment.
• Perform verification studies and or validations on new and modified processes to ensure process capability.
• Set up and/or modify assembly lines or cells utilizing lean manufacturing principles.

EDUCATION: 

•  BS/BA in Engineering or Manufacturing, AS considered with appropriate experience.

EXPERIENCE:

• Minimum 3-5 years in an industrial/manufacturing industry, preferable medical device manufacturing environment. Experience with GMP and ISO 13485 a plus.

ADDITIONAL SKILLS:

• Experience using 2D modeling software.
• Project planning
• Excellent communication skills including written and verbal reporting.
• Experience working with Catheters and Guide wires preferred.
• Lean Six Sigma experience a plus.

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