DEVELOPMENT PRODUCT QUALITY

ENGINEER

SUMMARY: Over 20+ years of diversified experience as Development Design /Supply Quality Engineer. Perform Development Quality, and tactical supplier quality duties, both in product R&D and manufacturing meeting Compliance Standards. Professional experience in Process Improvements, design controls, compliance Verification and validation plans, testing, and generation of test reports. Interface with development engineers, manufacturing engineers, product managers and participate in design reviews. Ensure compliance with current international regulations pertaining to EU MDR, FDA QSRs ISO 9001, ISO 14971, ISO13485, IPC 2221, IPC 2222, IEC 60601, IEC 60601-1-2. Work with cross-functional teams to improve processes and procedures, and implement changes as driven by internal and external factors. Monitor and measure performance of suppliers and report to management as required. Participate in Supplier Quality harmonization activities as new sites/businesses are acquired. Benchmark and network within TE and outside the company to develop new ideas, and drive these to execution. Collaboration with suppliers during development and product transfer in timely manner, Evaluate PPAP process documentation and ensure it’s aligned with Quality requirements / Agreement. Conduct onsite processes and product audits. Performed component, process and SMT issues and provided technical recommendation / solution. Followed up with suppliers to ensure GMP is applied as applicable.

MEDICAL EQUIPMENT:

Glucose Meter SaMD

Infusion Pump Mix Technology (Electrical, Mechanical & Software)

Catheter Generator Combination Product

Prefilled Syringe (PFS) Auto Injector

Mix Technology:

Software Code Review IPC 2222 Printed Circuit Board (PCBA) Design

Software Regression Test Gerber Files

Electrostatic Discharge (ESD) Surface Mount Technology (SMT) SME

PCBA Supplier Development PCBA Process Audit / Review

Integrated Circuit Semiconductor Device

In-Circuit Test Test Method

IPC 2221 PCB Design PCBA Line Design / Control

EXPERIENCE:

Senior Product Scientist Specialist III

Talentburst Contract 03/2022 – Current

Product development and compliance support of Merck Pre-Fill Syringe (PFS) Combination Products, interact with

cross functional internal and external team all levels. Developed Technical solutions, procedures, and systems to

ensure.

PFS compliance with FDA 21CFR 820’s and 21CFR 4 for Combination Product, ISO 14971 Device Risk Management,

and other applied regulations. Provided Device quality support and leadership and ensured success of prospective.

device.

product. Review and approve Design Control and Device Risk Management documentation for regulatory filings,

clinical.

supply, development, design transfer qualification and post marketing surveillance.

Responsibilities

Evaluated deficiencies and assessed impact on compliance status.

Contributed to developing/revising policy and procedures for MDCP Quality and/or supported areas.

Track with industry trends, regulations, and industry standards, and proposed necessary updates.

Provided guidance to ensure end-to-end Design Control principles are implemented effectively.

Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products.

Participated and supported in all stages of combo product development including but not limited to NPI and

supplier Quality.

Work with external partners to develop products.

Review and approve verification/validation test protocols and reports to ensure test methods will meet.

Regulatory requirements and quality objectives.

Provide input to design and manufacturing documentation including material specifications, drawings, inspection.

procedures, and manufacturing procedures, to ensure that the resulting products can be manufactured, And

tested.

Facilitate translation of customer needs into critical to quality and design input/output requirements, including but

not limited to chemical, physical, or performance specifications.

Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to

meet regulatory requirements and quality objectives.

Participate in all stages of combo product development including but not limited to oversight of purchasing.

controls and supplier

quality.

Design Quality Engineer III

Contract Philips Medical Dec. 2021 – 02/2022

Supported R&D and Post Market Surveillance teams supporting the design life cycle and transfer of the products into manufacturing, ensuring compliance with the Quality System Regulations, especially 21 CFR Part 803, 806, 820 and ISO 13485. Provided independent oversight for system and hardware quality during the design input process, design V&V activities, product realization and contribute to complaint closure, FI analysis and Quality Reviews.

Ensures appropriate quality and design plans are created that include all stages of the life cycle of the product. Perform Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, etc.) and prepare investigation reports.

Supported cross functional groups such as New Product Development and Sustaining Engineering to ensure Quality problems have been identified and contained.

Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.

Evaluation of complaint information received from clinical environments, such as device failure mode, manufacturing documentation review, labeling and instructions for use review.

Assist the Research and Development department to verify that modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use.

Ensure compliance to EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR)

Performs other duties as needed to ensure compliance with relevant FDA QSRs, EU MDR and other ISO regulations

Quality Manager Design Control

QA /QC Device & Combination Product

Pfizer Meridian Medical Technologies

12/15/2018 – 10/07/2020

Support research and development to help drive the design control process and ensure timely market authorization, actively lead and develop engineers and technicians through review and planning, training, performance management and feedback to meet the overall needs of the business.

Provide resource requirements for Auto Injector Development, and ensure resource availability to all projects. Assigns and reviews project work of development engineers, sets work priorities, and reviews projects deliverables.

Support project manager plans including achievements, validation processes and documentation procedures, Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.

Guide and support design assurance engineers during design control and risk management processes to ensure conformance to applicable standards and compliance with applicable laws and regulations. Ensure risk management is properly implemented and followed throughout the product lifecycle. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, Follows U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Sr. R&D Design Quality Engineer

Contract, Naples Florida, 12/04/2017 – 12/5/2018

Assist product development and supply quality teams with design requirements, verification testing methods, and helping to ensure the team is in compliance with applicable processes and regulations. Coordinating failure investigations with engineers and suppliers, seek SME as require and participate in preparing failure investigation and analysis reports, Lead DFME, DTM for new and existing product. Responsible supplier training on new technology.Recommending, planning and leading assigned corrective and preventative actions for continuous improvement, supporting design and process changes for current product and provide input and approval of qualification protocols and reports, leading or participating in risk management activities following ISO 14971 with the tools appropriate for various stages of the product lifecycle including DFMEA, PFMEA..

Responsibility

Evaluate procedures and processes within the quality system to identify areas for improvement, support international sites in China, the US, and Mexico Recommend solutions to identified problems. Engaged in sustaining engineering projects to plan, execute, verify and document commercialized product remediation. Carry out audits to ensure compliance company requirements Participate in Supplier Quality harmonization activities as new sites/businesses are acquired.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality engineering tests; and analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. Support areas of design control, process controls, verification /validation, production control, product evaluation and reliability as they apply to product or process quality. Supplier Onsite and remote support, training, consulting, and engineering assistance to manufacturing sites. Developing training, implementing, and providing ongoing support for design team quality system elements.

Electrolux, Anderson SC, 10/2013 – 12/04/2017

Senior North America

Global R&D Electrical Design Quality

Summary

Responsible for continually improve products supplier base. Drive supplier improvement efforts by partnering with Global Supply Quality Team, and collaborating with Electrolux other internal departments, such as Plant Quality, Overseas Supplier Quality teams, Engineering, and by working directly with Electrolux suppliers. Took care of all supplier data including all elements of supplier surveillance, maintains the accuracy & completeness of the supplier quality.

Responsible for North America design quality, China and Mexico supply quality.

Responsibility

Research; train North America personnel in science and application of Electrostatic

Discharge (ESD) awareness. Assist suppliers during process /product improvement.

Work with team to facilitate return product. Root cause analysis, Quality Improvements

Assure Quality Systems are in full compliance, ISO-9001, EN60335, IEC60730 and international quality

Covidien (MAYA) San Jose, CA 1/2013 –12/2013

Contract Sr. Principal Hardware Quality Engineer

Summary

Provides global Supplier Quality engineering management support to the Business and its

Suppliers of direct materials and services. Provides support to the development of Performance.

Management and Change Management Programs utilizing the best practice models for Supplier.

Quality while meeting all regulatory requirements in the respective markets and regions. Key is

supporting the quality planning process to drive continuous improvement and changes of

Covidien supplier quality process to ensure ongoing effectiveness and efficiency.

Responsibility

New product development and sustaining products Establish & implement supplier quality procedures in adherence with global policies & guidelines, ensuring efficient continuous monitoring systems are in place

support of quality assurance programs, policies, processes, procedures

Controls in Compliance, US and global requirements

Act as a subject matter expert involving quality system elements including hardware work products to ensure compliance.

System-level project / programs work products (e.g., plans, requirements, specifications, tests

test results, traceability, risk management documents, reports)

Facilitate and coordinate multiple cross-functional group.

Risk management program, change impact assessment program and product process risk.

Masimo Inc. Irvine CA, 1/2010 – 12/2012

Senior R&D Design Quality Engineer

Summary

Ensuring process compliance and achievement of targets by monitoring and coaching

Ensuring and improving supplier quality in the location / factory

Implementation and controlling of the efficiency of SQM-related BU Business Unit processes (process framework SQM incl. sub-processes, guidelines, procedures, tools)

Setting SQM targets in consultation with interface partners Responsible for implementation and controlling of an effective and efficient incoming goods inspection

Implementation and controlling of an effective complaint's management including review of effectiveness of corrective measures performed at the supplier.Regular analysis of supplier quality and support with fast and competent root cause failure analyses and technical knowledge when determining and implementing appropriate corrective measures at the supplier.

Responsibility

Identifying potential risk suppliers from the location / factory SQM point of view and introduction of adequate measures and ensuring that potential risks in the material's manufacturing process are reduced/avoided on a lasting basis

Controlling corrective measures including specific measures. Quality Engineering technical leadership, Lead Project Teams Root cause analysis, continuously improve quality, cost and time factor, Reliability and improvements. Support Failure and Complaint Investigations.

Conducts supplier quality system and product audits as needed.

Dexcom Inc. San Diego CA, 11/2008 - 1/2010

Senior R&D Electrical Quality Engineer

( Implantable Diabetes Monitoring)

Summary

Provide Supplier Quality Engineering leadership for manufacturing sites in Juarez (Mexico), Shenzen (China), and Ireland.

Process Development and Product Qualification of supplier product for New Product Introductions, including product acceptance strategies

Manage and resolve supplier quality performance issues in conjunction with site functions.

Support or lead continuous improvement initiatives driving supplier risk reduction.

Responsibility

Product development quality design, Design reviews, Design Control,

Product Validation / Verification Quality agreement, supply quality, Supplier training,

PCBA's process improvement, Master Validation Plan, Validation Plan

Manufacturing MIP's, SOP's, Manufacturing Operation Process Plan, Incoming Inspection Methods, Complaint Investigation, Risk management (DFMEA). Feasibility study to Product released, directly supervises 5 employees in the QA department.

Corrective actions related to audit findings, nonconforming product.

EDUCATION

Northwestern Polytechnic University, Fremont, CA

Doctorate, Electrical Engineering (2012)

MS Electrical Engineering (2006)

Cogswell Polytechnic

BS Electrical Engineering (2001)

CERTIFICATIONS:

Certified PCBA IPC TRAINER

Certified Advance IPC Electrical Designer

Certified DFSS

Lean Manufacturing Training

Kaizen Method Certified

ASQ Quality Manager Training

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