Job Details

JOB TITLE:                          NPI Quality Engineer

DEPARTMENT:                  Quality Department

REPORTING TO:                Quality Engineering Manager

DIRECT REPORTS:          N/A

OBJECTIVES OF POSITION:

• Primary objective is to introduce any New Customer product effectively ensuring all requirements of Customer and IPC standard for PCBA assembly is achieved. Principal customer interface for NPI Quality, responsible for ensuring all procedures are adhered to and that all aspects of New product Introduction are documented and recorded effectively and that opportunities for product and process improvement are captured in the set up phase by reviewing and providing constructive feedback to the internal and external Customer teams.  Overall objective is to provide a stable procedure based template to drive effective New Product Introduction ensuring component to PCB footprint design is evaluated effectively and that required validation activity including process FMEA, Control plan and Quality Plan for Customer cover all the necessary requirements.

RESPONSIBILITIES:

Quality: 

•     Assure ongoing compliance with quality and industry regulatory requirements

Health & Safety:

•     Ensure compliance with Health & Safety Legislation and Regulations.

• Management of all Quality requirements and approvals required to achieve first time approval of NPI introduction based on Customer requirements. Generation of standard NPI Quality template to drive robust approach to all NPI activity. Overall responsibility for generating comprehensive Quality plan and associated DHR appendix covering all Customer requirements as per any applicable Quality agreement. Overall responsibility for generating comprehensive team compiled Control plan and FMEA including process challenges and validation requirements prior to IQ/OQ/PQ phase.
• Data collection, analyzing and reporting of all NPI activity including standard template to document all NPI issues and concerns..
• Pareto and trend analysis of all NPI activity.
• Initiate and drive Continuous Improvement programs based on NPI / Engineering prototype builds from Surface Mount assembly to any associated Post SMT Surface Mount Assembly requirements..
• NPI Approval including First Article Inspections and Reporting.
• QSR Validation protocols and report (IQ, OQ & PQ).
• Effective step by step release and Quality checks of all New Product introduction phases covering risks in supply chain, component and material selection and fit for purpose suitability.
• Implement a detailed step by step Standard operating procedure that effectively covers all aspects of effective New Product introduction. Make NPI process more objective based with emphasis on minimum requirements for base line NPI process effectiveness utilizing SOP mentality and evidence based checks for all steps required in NPI process.
• Introduce objective Transfer to Manufacturing approval process ensuring each NPI is released to normal production with all aspects of the process defined and working to the required set out in Process Qualification phase.

MEASUREMENTS:

• Yields at Key Process Steps for all NPI activity
• Customer Return % and Cost (RMA)
• Scrap %
• Outgoing Inspection DPM & Customer Incoming Quality Levels
• NPI success rate and post shipment trending
• NPI reports covering effective and detailed action list identifying area for improvement / owners of actions and definitive follow up and closure of open actions prior to any follow on manufacturing.

PERSONNEL SPECIFICATIONS

 ESSENTIAL:   

• Degree / Diploma in Science or Engineering, or a lesser qualification with 5-10 years sufficient job related experience in a PCBA printed Circuit board assembly environment.
• Must have in depth knowledge of Surface Mount Technology assembly lines and associated Post SMT process control such as In Circuit Test, Flying Probe, Functional Test, Quality sampling and Batch release control.
• At least 2-3 years Quality Assurance / Regulatory affairs experience, in a similar Quality Engineering role in the electronics manufacturing industry.
• Sound understanding and utilization of Problem Solving Techniques
• Must have indepth understanding of IPC-A-610 manufacturing of printed circuit board assembly standard and clearly understand requirements of the standard.
• Proficient in the use of Microsoft Word, Power-point and Excel.
• Good Communications and strong influencing skills as well as ability to define New Product Introduction Quality controls from Purchasing controls to final shipment controls must have in-depth knowledge of entire process required to introduce new products.
• Ability to respond to common inquiries or complaints from internal customers and regulatory agencies. 
• Ability to write standard operating procedures, training documents, and regulatory responses.   

DESIRABLE:      

• Experience in working within a Class 3 Medical Device Manufacturing Environment.
• Six sigma Green or Black Belt Certified
• Knowledge of PCB Printed circuit board design requirements versus IPC standard.
• Experience of working with Fuji Surface Mount equipment such as solder paste inspection, NXT placement machines, Reflow oven criticality, Automated Optical inspection and general Statistical process control as well as familiarity with product testing such as In Circuit test, Functional test platforms.