Senior Product Engineer (PCBA)
The employer is from Finance sector. Study customer's technical requirement to ensure the PCBA manufacturing In-Circuit Test & Function Test (ICT/FCT) coverage are met during NPI and Mass Production stage. Well versed with standard design processes to perform design analysis with DFMEA, DFX, TSA to identify design related root causes and ensure successful product launch. Perform failure analysis for root cause investigation and troubleshoot all manufacturing line related problem using quality tools/techniques (Control Charts, Pareto Charts, Cp/Cpk analysis). Perform validation on test equipments used in production including GR&R, IQ, PQ and OQ. Revise qualification and validation plan when ECN is initiated. Drive continuous improvement for both design and processes to ensure cost-quality effectiveness. Lead and plan prototype builds, engineering builds, pilot builds and qualify necessary manufacturing processes for mass production. Liaise with R&D and Manufacturing engineers, and interphase with customers on technical/quality issues to achieve manufacturing KPIs. Coordinate with cross functional team (production, process, QA) to improve manufacturing/yield to ensure PCB quality is maintain. Worked with an interdepartmental team to establish tester qualification requirements for new testers and for changes to existing testers. Create a customer-specific return materials authorisation (RMA) process to meet the quality and production needs of the customer, including quick on-site rework turn-around time and comprehensive failure analysis reports for critical failures. Bachelor Degree in Electrical/Electronics Engineering with 5 years working experience. Familiar with PCBA design change verification and validation process (IQ, OQ, PQ), preferably from life-science product manufacturing industry. Experience in using quality tools and design analysis tools (FEA, DOE, DFX, TSA). Familiar with Engineering Change Process Management, Yield Reporting would be good. Familiarity in ISO 9001, ISO 13485, and FDA 21 CFR Part 820 is a plus. Strong communication and presentation skill as this role is client-facing.