Manufacturing Engineer

The Manufacturing Engineer will provide manufacturing engineering support to manufacturing lines producing Class III long term implantable medical devices. The manufacturing operations involved may include the following:

• Silicone Rubber Molding
• Crimping
• Resistance Welding
• Laser Welding
• Adhesive application
• Cutting/Trimming
• Flushing
• Curing/Annealing
• Inspection and Testing

Responsibilities: Daily interaction with the manufacturing teams providing hands-on support and troubleshooting of manufacturing processes and equipment. Provide detailed engineering analysis and documentation in the management of material disposition, manufacturing process updates, qualification activities, compliance activities, and CAPA's.

Work with the calibration and maintenance groups to ensure that equipment maintenance and calibration is completed on time.

Perform Equipment Installation, Mfg Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation for manufacturing equipment and processes. Generate all related documentation in compliance with internal and external requirements.

Support manufacturing facility transfer and product transfer activities to offshore facilities.

Develop technical solutions to difficult problems, finding solutions that are thorough, practical, and consistent with organization objectives.

Ensure personal understanding of all applicable quality policy and quality system procedural requirements. Complete required training on time.

Qualifications:

• BS in Engineering
• 5 years minimum engineering experience in the medical device field
• Experience with manufacturing process qualification (IQ/OQ/PQ), Software Validation, and Test Method Validation
• Experience with the FDA QSR and ISO13485

Qualifications:

• Experience with Class III medical device manufacturing.