Greg Wu Email & Phone Number

Amsterdam, Noord-Holland, Nl

• Represent quality department as cross-function team lead for medical device portfolios, new product development projects and product change projects. Ensure the design control requirements are being met in an effective manner, including design verification, validation, specification and procedure development, risk management and design review.• Ensure robust final product testing is designed, developed and implemented.• Review design history technical files (DHF) for conformance to applicable requirements and regulatory standards.• Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment.• Develop risk management plans, perform product risk assessment, facilitate the failure mode effects analysis, and create final risk management reports.• Develop and implement product reliability assessments.• Review new or modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.• Provide support for product complaint investigations and ensure rapid resolution of product complaints and/or safety issues.• Manage risk management process and post market feedback review and updates.• Perform and/or support audits (internal, external, and by regulatory agencies) and risk-based supplier assessments.• Be familiar with ISO 13485, ISO14971, 21 CFR 820, CMDR, MDD and 21 CFR 210 and 211 and ISO 9001.• Experience in risk evaluation and investigation techniques, such as failure analysis and root cause determination, CAPA, DFEMA, PFMEA, IQ, OQ, PQ, control plan, V&V plan, Cpk, SPC, DOE, process data analysis and DMAIC etc.• Skilled in statistical methods, gauge R&R, statistical process control, sampling plans, and design of experiments.

Billerica, Ma, Us

Responsible for all quality aspects of design, manufacturing and customer support for complex electro-mechanical products. Ensure the products meet quality and reliability requirements.• Represent quality department as cross-function team lead for product portfolios, new product development projects and product change projects. Ensure the design control requirements are being met in an effective manner, including design verification, validation, specification and procedure development, risk management and design review.• Lead cross-functional team (including marketing, finances, design, supply, manufacturing, warranty, etc.) in new product introduction / development (NPI/NPD) process. Develop, update and release of FMEA, Risk Management Plan, Hazard Analysis and FTA (Fault Tree Analysis).• Lead the use of reliability tools and testing in NPD process. Develop and execute quality / reliability tests (highly accelerated life test, accelerated life test and thermal humidity bias test etc.) to validate the robustness and design function of new product.• Team leader audits contracted manufacturers and suppliers (China) to make sure products, components, mechanical tooling and manufacturing process meet requirements.• Strong and thorough knowledge of quality improvement tools including FMEA, SPC, MSA, DOE, CAPA, 8D, Gage R&R, Six Sigma and material certification etc.• Develop and generate all necessary documents (quality plan, design qualification and test plan, quality / reliability report, final quality report) to ensure the product meet requirements• Develop design qualification and test plan to ensure product design, quality, reliability, function, regulatory, safety, cost and schedule to meet the targets.• Lead the failure investigation, root cause analysis, performing corrective action for customer related failures and facilitate customer quality and reliability interactions.• Familiar with ISO9001 & ISO13458 and others quality systems.

Burlington, Massachusetts, Us

Responsible for assigned products quality, reliability and safety related aspects during the product NPI/NPD process. Ensure the complex electro-mechanical product meet reliability and quality requirements.• Project leader for developing innovative mechanical / electrical solutions for the complex mechanical-electrical consumer products. • Team leader interfaces with different departments (design, supply, manufacturing, marketing and finance, etc.) in new product introduction / development (NPI/NPD) process (from concept, development, test, qualification to final product etc.)• Develop and execute quality / reliability tests (accelerated life test, highly accelerated life test, and environmental life test) to validate the robustness and design function of new product.• Team leader audits contracted manufacturers and suppliers (China) to make sure products, components, mechanical tooling and manufacturing process meet requirements. Statistical tools include 8D, FMEA, SPC, Gage R&R, Cpk, FAI, Six Sigma and material certification etc.• Develop and generate all necessary documents (quality plan, design qualification and test plan, quality / reliability report, final quality report) to ensure the product meet requirement / specification.• Co-operate with design team to support mechanical / electrical related activities throughout design, development, manufacturing, marketing and etc. NPD process.• Project leader for making root cause analysis and perform corrective action and to ensure the continuous improvement of product quality.• Build new reliability models or use other models (Weibull, lognormal etc.) to analyze the time-to-failure data, performance degradation data and field data (warranty).• Apply quality tools, techniques and methodologies (8D, FMEA, DOE, DFR, RCA, SPC, QFD, Six Sigma, Risk Assessments, GR&R and Cpk etc.) to ensure the development of robust product.

Chelmsford, Ma, Us

Responsible for assigned products reliability and quality and safety related aspects during the NPD (new product development) process. Ensured the complex electro-mechanical product meets reliability and quality requirements.• Lead to develop and manage reliability test plans for assigned products. Including design test method, test stresses, test time, sample size, test result record and failure mode analysis.• Team leader interfaces with different departments (design, supply, manufacturing, marketing and finance, etc.) in new product introduction / development (NPI/NPD) process (from concept, development, test, qualification to final product etc.)• Develop reliability analysis models to estimate reliability, MTBF and failure rate based on test data and warranty data for all products. Use statistics method such as DOE (Design of Experiment) to improve and optimize product design.• Develop design qualification and test plan to ensure product design, quality, reliability, function, regulatory, safety, cost and schedule to meet the targets.• Perform 8D, FMEAs, DOE, SPC, Gage R&R, RCA and FRACAS to improve product design. Used scientific system method to solve problems. Built reliability growth program.• Define and develop the reliability test procedures and quality control procedures.• Use DFR (Design for Reliability), Six-Sigma DMAIC (Design, Measure, Analyze, Improve and Control) and SPC (Statistics Process Control) to improve product reliability and quality.• Familiar with FDA and ISO regulations.

Nashville, Tn, Us

Responsible for assigned products reliability and quality and safety related aspects during the R&D (research & development) process. Ensured the reliability and quality requirements within new product development (NPD) process were met. Analyzed manufacturing process problem and improved product quality.• Lead to develop reliability test plans for assigned products. Including design test method, test stresses, test time, sample size, test result record and failure mode analysis.• Develop and execute quality / reliability tests (accelerated life test, salt spray test, corrosion test, high pressure test and environmental life test) to validate the robustness and design function of new product.• Develop reliability analysis models to estimate reliability, MTBF and failure rate based on test data and warranty data for all products. Use statistics method such as DOE to improve and optimize product design.• Perform 8D, FMEA (Failure Mode Effective Analysis), DOE, SPC, Gage R&R, RCA (Root Cause Analysis) to improve product design. Used scientific system method to solve problems. Build reliability growth program.• Define the reliability test procedures and quality control procedures.• Use Weibull++, Item, Relex, Minitab, Mathcad, Blocksim and ALTA etc. software to analyze product reliability.• Use Six-Sigma DMAIC (Design, Measure, Analyze, Improve and Control), SPC to improve product reliability and quality.• Train design engineers and other engineers to understand reliability / quality techniques and how to perform reliability test and data analysis.• Familiar with FDA and ISO regulations.

Master Of Science, Reliability And Quality Engineering

Master Of Science, Mechanical Engineering

Bachelor Of Science, Mechanical Engineering