Manufacturing Engineer II

General:

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrates knowledge and acts in accordance of NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Abide by all safety and security rules set forth by the company and regulatory agencies
• Regular attendance is required.

Production Support and Troubleshooting:

• Provide engineering support to manufacturing operation on routine basis.
• Address product related issues arising on the production floor.
• Investigate non-conforming materials and products from receiving inspection and the production floor.
• Initiate and own CAPAs as necessary.
• Support supplier quality issues and changes in conjunction with the buyer.

Customer Support

• Provide the customer with a dedicated SME for their product line.
• Implement changes required by the customer and request changes to their production lines as needed.
• Investigate customer complaints with Quality when necessary.

Continuous Improvement and Cost Reduction:

• Continually improve manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs.
• Identify and evaluate opportunities for improvement and make specific recommendations for adoption.
• Perform cost analyses to reduce or optimize product costs.

Concurrent Engineering:

• Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
• Ensures compliance with GMP's and internal protocol.
• Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations.

Equipment and Fixturing:

• Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters.
• Collaborate on design with suppliers to fulfill equipment and fixturing requirements.

Qualification and Validation:

• Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.

Documentation:

• Define and generate all required documentation in support of manufacturing products and processes. These include: ECOs, Engineering protocols, FMEAs, reports, manufacturing instructions and procedures.
• Maintain a high level of documentation that is clear and understandable, contains pertinent and accurate information, and will promote confidence with customers and auditors.

• Bachelor's Degree in Engineering
• A minimum of 3 years of experience in a manufacturing or productions environment
• Solid interpersonal and communication skills and ability to work in a team environment
• Experience with CAPA's, MRB's, and/or NCMR's
• Experience with statistical analysis of Production processes
• Current or recent experience with equipment and/or process qualifications and validations (IQ,OQ, PQ)
• Experience writing protocols, reports and engineering change orders
• Advanced degree in Engineering preferred
• One year of medical device manufacturing or manufacturing in highly regulated environment preferred
• Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11 preferred
• Experience designing and conducting DOEs using MiniTab preferred