Project Management Six Sigma

Ralph H. Koussa

**** ******** *** #****, ******, CA 92782

Mobile : 413-***-****

Email : ************@*****.***

Education

• Wright State University

MBA; Project Management,

2004

• Wright State University

BS, Mechanical

Engineering, 2000

Skills & Experience

• Quality Systems & Regulatory

• Communication

• Leadership

• Post Market Surveillance

• Statistical Analysis/Minitab

• Multi-Tasking

• Process Design & Control

• Project Management

• Six Sigma/Lean

Manufacturing

• Compliance & FDA

Regulations

• Team Player

• Testing Equipment

Computer Applications

• Solidworks

• Minitab

• MS Office Package

• MS Project

Certifications

• Lean Manufacturing

• Six Sigma Green Belt

Training

• Design and Process FMEA

training, May 2010

• GE Design for Six Sigma

Green Belt training, June

2008

• Tyco Healthcare Lean

Manufacturing training and

certification, April 2006

• ISO 13485: 2003 Internal

Audit Certification, June 2005

• Process Validation training,

April 2005

Summary

Diversified Medical Device Engineering experience in high and low volume production with an extensive background in Quality Assurance, Manufacturing, Mechanical, Processing, Validation engineering and Management

Work Experience

Principal Manufacturing Engineer – JenaValve Technologies, Inc. May 2023 - Present Irvine, CA

• Establish manufacturing assembly line for a delivery catheter in a Class 7 Clean Room. Perform process validation, design assembly fixtures, create work instructions and routers, train operators, define in-process and final inspection criteria.

• Lead Delivery Catheter packaging qualifications across functional teams identifying test requirements, sampling plans, acceptance criteria and reporting test results.

• Create 3D models and detailed drawings for design components and test fixtures for feasibility studies. Coordinate with internal and external partners on design requirements and specifications.

• Key contributor supporting supplier validation activities for injection molding components for delivery system manufacturing. Provide technical input pertaining to process characterization, critical process variables, process outputs and risk mitigation.

• Execute supplier Quality System Audits. Initiate containment action, investigation plan, risk review and develop corrective action plan.

• Provide design and development expertise to the R&D function in the areas of design for manufacturability, design iterations testing, failure mode analysis and Root cause analysis.

• Improve production throughput by incorporating design for manufacturability methodology in component designs of delivery catheters.

• Mentor junior engineers pertaining to engineering principles and guidance. Senior Manufacturing Engineer – Medtronic [Contractor] March 2022-November 2022 Irvine, CA

• Technical Lead role - provided technical and sustaining engineering support for the execution of remediation validation and verification activities on the Axium Coils production line

• Performed process and software validations including Operations Qualification

(OQ), Process Qualification (PQ)/ Process Performance Qualification (PPQ), Test Method Validations (TMV’s), Process Characterization for CAPA remediation activities

• Authored engineering change requests, review and collaborate for approval across engineering functional groups and incorporated changes to close out remediation activities

• Performed geometrical tolerance stack up analysis on assembly components to ensure proper fitment and conduct First Article Inspections

• Performed statistical analysis including Capability Studies, GR&R, Attribute Agreement Analysis

Senior R&D Engineer – Balt USA [Contractor]

August 2021-February 2022 Irvine, CA

• Reporting to the VP of PMO, provided technical leadership and guidance in design and development to a cross functional team of engineers and technicians on the design to manufacture transfer of Next Generation Aspiration catheters

• Identified design specifications and procure manufacturing equipment (Coil Winder, Braider, Laminator, UV and Thermal Hydrophilic Coating equipment) to meet product design requirements. Performed acceptance testing on new equipment to ensure compliance with design specifications and intent of use

• Coordinated manufacturing equipment transfer, installation, and technical training

• Proposed and implemented complex design modifications to existing manufacturing equipment to improve capacity and reduce cost of operation.

• Set up pilot manufacturing assembly line, drew up equipment validation plan, wrote manufacturing documentation, trained technicians, DOE’s, IQ, OQ and PQ protocols and reports

• Created test methods for feasibility and verification and validation testing. Performed test method validations, capability Created manufacturing work orders, part numbers, items masters, BOM’s, ECO’s, routed and released change orders

• Provided project updates to leadership pertinent to timelines, status and results Senior R&D Engineer – Medtronic [Contractor]

September 2018-August 2021 Irvine, CA

• Led cross functional team to develop molding process for catheter component in partnership with supplier

• Established component design specifications, defined process validation requirements and managed overall project cost and timeline

• Designed, developed, and validated test methods to support transfer of product design to manufacturing

• Performed Design History and Product Specification Gap Assessments and established remediation plan

• Investigated root cause analysis, determined failure mode as well as contributory factors associated with failure mode for design validation testing

• Prepared technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.

• Provided guidance to technicians and junior engineers Complaint Analyst – Advanced Sterilization Product [Contractor] November 2017-September 2018 Irvine, CA

• Led complaint investigations on new and existing products, documentation, investigate, review and approval of DRA’s, non-conformances and CAPAs

• Created and reported on daily complaint processing timeliness and aging matrices to meet complaint team goals and deliverables

• Mentored and trained new complaint analysts on various aspects of the complaint handling process

• Interacted and collaborated with Cross Functional Teams to complete complaint investigation process, assign Product Experience Codes and determine FDA reportability

• Evaluated all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure

Staff Quality Engineer – Advanced Sterilization Product [Contractor] January 2017-August 2017 Irvine, CA

• Supported project launch in meeting launch stability metrics including Post Market Surveillance Plan, Product Experience and Failure Analysis Codes

• Created and updated New Product Quality Plan, Safety Surveillance Plan, and Risk Management Plan for new product introduction

• Established and executed training plan for new product troubleshooting and diagnostic process

• Executed and reported on Gap analysis on New Product Quality Planning procedures

Quality Assurance Engineer – Sechrist Industries [Contract to Permanent] July 2016-January 2017 Anaheim, CA

• Processed customer complaints, trending, and reporting of quality metrics, performed CAPA root cause analysis, identified corrective action and defined implementation and effectiveness plans

• Provided technical guidance to junior engineers on quality and engineering disciplines to develop solutions to complex problems

• Conducted Supplier Quality system audits as a team member of the audit team and prepared audit reports

Staff Manufacturing Engineer – Heart Valve Therapy, Edwards Life Sciences April 2015-May 2016 Irvine, CA

• Led a team of engineers and reported on a Lean Manufacturing event to optimize and streamline a manual assembly process

• Established Parts Acceptance Process for suppliers’ molded components including Sampling plans, First Article Inspection, Inspection Methods, Measuring Systems, and Gauge R&R

• Performed validations for new equipment and processes Senior Manufacturing Engineer, Dielectrics, INC.

May 2011- March 2015 Chicopee, MA

• Reporting to the VP of R&D served as a project lead on numerous New Product Introduction projects

• Managed and supervised 2 engineers and 3 technicians on multiple projects, setting project goals, daily tasks and providing technical guidance

• Conducted process validations with activities including writing and executing of protocols for all steps in the validation process (IQ/OQ/PQ)

• Performed Process Engineering and Six Sigma DMAIC activities which included the following: process capability studies, design of experiments (DOE), process maps, cause and effects matrices, PFMEA’s, SPC, Statistical Analysis, Measurement System Analysis (MSA)/Gage R&R, ANOVA, Sampling Plans

• Managed and Performed Product Quality activities which included the following: Customer quality interface, Customer complaints, Non-conformances, CAPA’s, Supplier Quality and root cause analysis

• Created standard operating procedures, Device History Records, Purchase specs for new produce designs

Manufacturing Engineer Team Lead, Cirtec Medical Systems December 2009 – March 2011 East Longmeadow, MA

• Provided both Functional and Technical Supervision to a manufacturing engineering team in the areas of process development, process improvement and streamlining, as well as project management

• Mentored, directed, and assigned daily tasks as needed based on project risk factors, leadership guidance and company directives

• Directly supervised 2 Engineering Technicians, Executed employee job performance reviews, evaluations, and appraisals

• Utilized process control charts and lean techniques to revamp several production lines to increase productivity and overall product quality Mechanical Engineer, GE Infrastructure - Transportation April 2007 - November 2009 Erie, PA

• Performed root cause analysis on field failures, DFMEA, JSA, design analysis, solution, and implementation

• Generated field maintenance instructions and repair specifications associated with design modifications

• Interfaced with designers and drafters on designs, detailing and releasing of components and systems for both new and current products Manufacturing Process/Validation Engineer, Covidien February 2004 – April 2007 Cincinnati, OH/Chicopee, MA

• Led continuous improvement teams to resolve daily production problems and explore areas of opportunity

• Led internal quality audit teams to ensure compliance with FDA regulations

• Incorporated lean manufacturing and Six Sigma tools to eliminate waste and increase productivity in commercial assembly lines

• Developed testing methods to improve quality and reduce costs for new and existing medical devices

• Supported the review and approval of NC’s & CAPAs related to process changes Project Engineer, Fujitec America, Inc.

January 2000 – August 2004 Lebanon, OH

• Designed components and layouts for various types of elevator systems

• Investigated new designs to provide cost reduction, standardization and streamline production

• Prepared and ordered specs for high profile custom and standard elevator systems

***References Available Upon Request***

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