Nellie Stewart
Cincinnati,OH
Summary
Manufacturing and New Product Development Engineer with 20+ years of experience, a passion for improving quality, manufacturing processes, and efficiencies, and introducing new and redesigned existing products into manufacturing, production launches, and post-launch sustaining engineering. Well-versed Senior Manufacturing Engineer with 20 years of experience in medical device manufacturing engineering. Skilled at streamlining processes and introducing systems of organization. Competent at cutting costs without sacrificing quality and leading by example. Resourceful Manufacturing Engineer with 20 years of experience. Trained in leadership and medical device design with extensive knowledge of production floor maintenance. Successful at cultivating relationships with vendors and clients. Determined leader eager to leverage knowledge in engineering principles and concepts. Skilled in implementing manufacturing processes, developing production systems, and analyzing product designs. Smart and dedicated to cost-saving initiatives and process improvements. Top-notch Manufacturing Engineer with proven expertise in designing and developing manufacturing processes, equipment, and layouts. Skilled in troubleshooting with a strong knowledge of lean manufacturing principles. Adept at using statistical process control and quality control methods to improve production. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Senior Manufacturing Engineer
Interplex Medical
07.2022 - Current
- Assist with development of medical device products through development, testing, validation, and manufacturing scale-up
- Establish and maintain manufacturing documentation and drawings
- Recommend and implement manufacturing tooling and fixtures
- Support daily manufacturing and operations activities
- Develop and execute IQ, OQ, and PQ qualifications of processes and equipment
- Coordinate non-conforming material and CAPA activities
- Facilitate problem-solving, root cause analysis, and continuous improvement activities.
- Reduced product rollout time by 48% using effective multitasking on design, engineering and manufacturing
- Developed streamlined manufacturing process, which boosted productivity.
- Applied statistical methods to estimate future manufacturing requirements
- Reviewed products for compliance with Design for Manufacturing (DFM) requirements
- Served as technical liaison between customer, manufacturing, quality assurance and vendor and supplier personnel to resolve technical and quality issues
- Performed concurrent design and manufacturing engineering and other functions to reduce time required to bring product to market
Manufacturing Quality Engineer
Guerbet
06.2021 - 07.2022
- Create work instructions and training for urology table assemblers in the Urology department
- Performed staging and testing activities for urology tables to be delivered to customers
- Investigate and disposition non-conforming materials for the Urology Department
- Investigate and provide trending for field complaints for the Urology department
- Participated in MRB activities to ensure timely resolution of material non-conformance and corrective action
- Conducted qualifications, verifications, and validation studies in support of product and process changes
- Developed, implemented, and reviewed procedures and work instructions to ensure compliance with regulatory and quality requirements and continuous improvement activities
- Performed reviews and updates of Technical Files, Design History Files, Device History Records, and design changes
- Developed, reviewed, and approved engineering change orders for compliance and product improvements
- Performed Process Validations (IQ, OQ, PQ) for new product transition from Research and Development to manufacturing and production
- Managed, coordinated, and participated in activities for investigations regarding customer complaints
- Investigated and provided failure analysis of products, components, and/or systems for identification of root cause, corrective, and preventative actions
- Provided supervision, coaching, and mentoring to Quality Technicians, Inspectors, and assembly operators.
Manufacturing Engineer
Guerbet
04.2016 - 06.2021
- Directed manufacturing positioning of new product introductions and existing product improvements for contrast media injectors, injectors power supply upgrades, replacements for end-of-life components, and developed manufacturing and assembly processes
- Provided daily manufacturing support for production work cells, and improved product quality and employee morale by empowering employees
- Certified trainer for acceptance requirements for cables, wire harnesses, and electro-mechanical assemblies
- Managed integration of new products, processes, and equipment into manufacturing and production
- Developed and implemented new packaging methods that resulted in 87% reduction of Failures Out of the Box (FOOB) for products shipped to APAC countries
- Created and implemented new formats for documenting work instructions and routers that removed ambiguity, provided clarity, improved quality, and decreased training time by 12.5%
- Developed and executed protocols, reports, and engineering studies for IQ, OQ, and PQ activities to qualify processes and implement new equipment on the manufacturing floor
- Troubleshoot/Analyzed non-conforming products, materials, field complaints, and product returns, and provided root cause analysis using 5 WHY(s) analysis, FMEA(s), Fishbone diagrams, 8D and statistical analysis (Minitab)
- Participated as a member of the Materials Review Board analyzing, investigating, and disposition non-conforming components and products
- Trained/Certified assemblers, engineers, inspectors, and technicians as a CIS (Certified IPC Specialist) to the IPC/WHMA-A-620 for requirements and acceptance of wire and cable harnesses
- Partnered with external suppliers to develop processes, reduce costs, and improve the quality of components and products.
Manufacturing/Sustaining Engineer
Hill-Rom
03.2014 - 04.2016
- Manufacturing/sustaining engineer responsible for providing root cause analysis of product field complaints
- Manufacturing engineer supporting daily activities of manufacturing
- Collaborated with design engineers, manufacturing engineers, quality engineers, and assemblers to make product design modifications and use DFA/DFM methods to improve quality, decrease product returns, and decrease field complaints
- Created and executed protocols, and reports for IQ, OQ, and PQ activities to qualify and document processes and equipment
- Complaint Investigation Engineer for remediation project responding to FDA 483 Form
- Analyzed field complaints and product returns and provided root cause analysis using 5 WHY(s) analysis, FMEA(s), PFMEA(s), Fishbone diagrams, and other investigative tools
- Created work instructions for manufacturing and assembly processes.
Manufacturing/New Product Development Engineer
Ethicon
04.1997 - 11.2012
- the Facilitator/Supervisor with thirteen direct reports
- Responsible for hiring, coaching, mentoring, team building, and performance evaluations
- Reduced tooling repair costs for staple makers by $12,000 per month
- Responsible for scheduling resources to meet schedules, and reducing equipment downtime
- Collaborated with and participated as lead manufacturing engineer for cross-functional teams during product development (energy sealing and dissecting, surgical stapling, endoscopic and open ligation devices)
- Lead business initiative to expand knowledge and utilization of good GD&T practices for R&D engineers, manufacturing engineers, designers, CAD designers, quality, and suppliers
- Mentored, coached, and supported Six Sigma Green Belt and Yellow Belt candidates from initiation through completion of projects
- Trained direct reports and implemented SPC methods to visualize and analyze variables affecting downtime, service calls, spare parts, and process variations utilization
- Results were 15% decrease in chronically repeated calls for servicing equipment, and process improvements
- Decreased cycle time by improving equipment efficiencies
- Managed projects with internal and external suppliers developing injection molded, electro-mechanical, stainless steel, and titanium components
- Managed projects with equipment manufacturers for new equipment design, verification, and validation
- Managed off-shore supplier for injection molded components using bridge tooling resulting in approximately 40% savings for first year of production
- Responsible for the completion of documentation for final products and component approvals (control plans, capability studies, first article inspections, gage R&R, and metrology processes)
- Analyzed non-conforming products, materials, field complaints, and product returns, and provided root cause analysis and failure investigation reports.
Manufacturing Engineer
Diebold
07.1992 - 04.1997
- Manufacturing engineering responsible for the development of sheet metal components used for the manufacture of Automated Teller components
- Developed sheet metal layouts for fabrication processes (stamping, forming/bending, and welding)
- Provided fabrication and assembly processes for operations/plant floor production
- Completed a collaborative initiative with design engineers and manufacturing engineers to standardize tooling and fixtures used during fabrication processes (press brake bending and punching tooling) that resulted in a 14% decrease in purchasing tooling
- Responsible for process developments with plasma cutting of metal plates used for manufacturing and fabrication of automated teller machine enclosures.
Education
MASTER OF BUSINESS ADMINISTRATION - Business Administration
UNIVERSITY OF PHOENIX
Cincinnati, OH05.2008
BACHELOR OF SCIENCE - Mechanical Engineering
JOHN BROWN UNIVERSITY
Siloam Springs, AR05.1989
Associate of Applied Science - Electrical, Electronics Engineering Technologies
John Brown University
Siloam Springs05.1988
ASSOCIATE APPLIED SCIENCE - Machine Design and Drafting
PHILLIPS COUNTY COMMUNITY COLLEGE
Helena, AR05.1980
Skills
- Employee Supervision
- Process Improvement
- Minitab
- AutoCAD
- Risk Assessment
- Quality Control
- Lean Manufacturing
- 5S Organization
- Continuous Improvement
- Root Cause Analysis
- Cost Reduction
- Decision-Making
- Root Cause Analysis
Certifications Training
- Certified Six Sigma Black Belt
- Certified IPC CIT (Certified IPC Trainer) – IPC/WHMA-A-620 (expires 06/2023)
- American Red Cross Adult First Aid/CPR/AED Certificate (expires 09/2023)
- AutoCAD/AutoCAD LT 2018
- Kepner-Tregoe (Problem Solving and Decision Making for Root Cause Analysis)
- Principles of Servicing Diagnostic Imaging Systems Phase 1
Core Competencies And Strengths
- Leadership and Teamwork
- Medical Device Manufacturing
- Mentoring/Coaching/Team Building
- New Product Development
- Process Development/Verification/Validation
- FDA/GMP/ISO Requirements
- DFM/DFA Opportunities/Methods
- External/Internal Communication
- Six Sigma Certified Black Belt
- Troubleshooting/Root Cause Analysis
Certification
Six Sigma Blackbelt
Timeline
Senior Manufacturing Engineer
Interplex Medical
07.2022 - Current
Manufacturing Quality Engineer
Guerbet
06.2021 - 07.2022
Manufacturing Engineer
Guerbet
04.2016 - 06.2021
Manufacturing/Sustaining Engineer
Hill-Rom
03.2014 - 04.2016
Manufacturing/New Product Development Engineer
Ethicon
04.1997 - 11.2012
Manufacturing Engineer
Diebold
07.1992 - 04.1997
MASTER OF BUSINESS ADMINISTRATION - Business Administration
UNIVERSITY OF PHOENIX
BACHELOR OF SCIENCE - Mechanical Engineering
JOHN BROWN UNIVERSITY
Associate of Applied Science - Electrical, Electronics Engineering Technologies
John Brown University
ASSOCIATE APPLIED SCIENCE - Machine Design and Drafting
PHILLIPS COUNTY COMMUNITY COLLEGE
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