Manufacturing Engineer
Resume:
Martini Hilliard
Bartlett, TN *****
************************@***********.***
Professional Summary
Objective: To obtain an Engineering position, providing adequate experience for a senior-level engineer. Work Experience
Senior Manufacturing Engineer (Contract) - (RS4EP & Double Back) Medtronic Inc.-Memphis, TN
February 2021 to Present
· Collaborate with cross-functional teams that include specialists from Manufacturing, Regulatory Affairs, Product Development, Sourcing, and Finance to help develop, execute, and drive manufacturing transfer projects.
· Perform/review process validation using IQ, OQ, PQ
· Lead change control processes using Agile workflows.
· Execute projects within the constraints of budget, timeline, resources, and project performance requirements.
· Engage stakeholders of multiple functions to keep transfer updates current.
· Engage with cross-functional team members on continuous improvement ideas within the transfer process.
Senior Manufacturing Engineer III (Contract) - (UDI/EU MDR) Smith and Nephew Inc.-Memphis, TN
February 2020 to February 2021
· Manage 3 – 8 Product Development Engineers daily.
· Prioritize and schedule Engineering Changes by SKU, Franchise, US class, and EU class.
· Track Engineering changes/updates to the overall tracking file/database.
· Develop, revise, and publish UDI DPM Engineering Change Request (ECR) process.
· Train new Product Development Engineer Interns to the ECR Work Instruction/template and protocols.
· Coordinate with cross-functional teams to complete UDI drawing print updates in accordance with UDI phase II requirements.
· Prepare training materials and execute lesson learned workshops.
· Investigate and correct parts (BOM and Router) setups in Matrix & SAP, to assure completeness and correction of all batch classifications fields.
· Report regularly on the UDI team progress and schedule. Quality and Continuous Improvement Manager - (Tennessee Division) SFI Fabrication LLC.-Memphis, TN
September 2018 to December 2019
– Managed the
Manufacturing and Fabricating of heavy duty steel components for complex assemblies for (Caterpillar, Volvo, Great Dane, Utility, Hendrickson, Load King, and Ridewell)
· Manage 3 to 6 Quality Technicians daily.
· Ensure production is consistently meeting customer requirements.
· Review and lead PPAP discussions to finalize decisions of product production status for customers.
· Created Job Element Sheets, Control Plans and Process Flow Diagrams for each project launch.
· Lead and organize (FAI)First Article Inspection for new and revised product.
· Establish execution plans to ensure each customer product attain less than 1000 PPM each month.
· Problem solve and mitigate new and existing product requirements.
· Report regularly on continuous improvement to senior managers.
· Work closely with all functional groups (Sales, Engineering, and Manufacturing) to monitor quality expectations.
· Validate special processes.
Production/Manufacturing Engineer - (Plant Wide) – Manufacturing Orthopedics
Orchid Orthopedic Solutions Inc.-Memphis, TN
October 2017 to September 2018
Replacement Hips, Heart Valves, and Shoulders (Porous Coatings) and Medical Devices for (Smith and Nephew, Microport, Wright Medical, Lake Region, Amplitude, and ODC.)
· Oversee and approve Engineering Change Orders (ECO’s) for all products.
· Create and manage Device Master Records for all products to ensure we are in compliance with 21 CFR 820.181.
· Review and lead Process Characterization Protocols and Reports, Root Cause Analysis, Control Charts and (IQ, OQ, PQ) Validation protocols/reports, while utilizing statistical tools- Minitab to determine process Sigma levels, Cp, Cpk, Pp, Ppk, and DPMO.
· Create and Lead Process Maps, pFMEA, Control Plans, MSA, and other risk analysis tools.
· Create and update work instructions for NPI launches and special processes.
· Generate and approve furnace Uniformity Surveys per AMS 2750E. Project Manager Engineer - (Tennessee Division)
SFI Fabrication LLC.-Memphis, TN
May 2017 to October 2017
– Managed the Manufacturing and
Fabricating of heavy duty steel components for complex assemblies for
(Caterpillar, Volvo, Great Dane, Utility, Hendrickson, and Load King).
· Reviewed and led Gateway discussions to finalize decisions of product Design for Manufacturing Assembly (DFMA).
· Created work instructions, wield sequences and process flow diagrams for each project launch.
· Lead NPI kick-off meetings providing the team with detail timelines and deliverables.
· Established execution plans to ensure each customer product attain 95% on-time delivery.
· Negotiated with contractors and suppliers for materials and services.
· Reported regularly on progress to the customers and senior managers.
· Worked closely with all functional groups (sales, engineering, quality, manufacturing) to generate, monitor, and control schedules, budgets & requirements
· Prioritized project tasks based on capacity, due dates & critical paths. Manufacturing Engineer II- (Hip Division) – Manufacturing Orthopedics Replacement Hips and (Medical Devices.)
Smith and Nephew Inc.-Memphis, TN
September 2014 to April 2017
· Reviewed and led Process Characterization Protocols and Reports, Root Cause Analysis, Control Charts and (PQ) Validation reports, while utilizing statistical tools-Minitab to determine process Sigma levels, Cp, Cpk, Pp, Ppk, and DPMO.
· Created and Led Process Maps, pFMEA, MSA and other risk analysis tools. Create supplier candidate lists, and work instructions for a product launch.
· Monolithic- Delivered Monolithic Redapt as part of a balanced product portfolio to meet ASD customer needs in established markets, including delivery of key product launches and Milestones while ensuring acceptable safety and efficacy.
· Australia Up-classification- Performed a strategic plan in attaining the necessary documents to meet our Australia regulatory team deliverable date of June 30, 2014. We closed the gap on a 3-year plan for documents submissions bar 1 and preserved a $130M recon business completing a total of 148 submissions to TGA.
· Lean Black Belt Six Sigma (Burn Marks on Tibia Inserts) - To reduce the scrap cost due to burn marks defects by 50% by December 2015. This project will support our initiative to reduce the burden of scrap and expensive additional rework and achieve savings of an estimated $32,000 or more per year. Quality Engineer II
Tower International-Meridian, MS
May 2013 to August 2014
(Press Department) - Stamping Body, Rails, and Frames for
(Nissan-USA, Unipres, Toyota, and Honda-KTH)
· Analyzed and responded to customer complaints (internal and external), through SRIS system.
· Directed root cause analysis and team problem-solving activities using the 8D method.
· Assisted with plant activities to achieve quality, productivity, and cost reduction goals by a total of
$11,711.00 dollars in 2013-2014.
· Responsible for training quality colleagues on attribute Gages / Instructions, Inspection sheets, and how to analyze variable data.
· Supervised quality colleagues in support of customer satisfaction.
· Prepared ANPQP documentation for customer approval on the new product.
· Coordinated and perform Internal Auditing requirements.
· Prepared online quality reports for comparison and analysis for continual improvement. Product Launch Engineer- Manufacturing Cooling Systems for (John Deere, AGCO, CNH, and PACCAR)
Adams Thermal Systems-Sioux Falls, SD
May 2012 to February 2013
· Designed and overseen the installation of processes, equipment, and tooling to support new programs in the production plants. Established and updated all programs routings. Created work instructions for all-new programs.
· Led the development of PFMEAs and participate in the development of DFMEAs.
· Conduct and support process capability studies, control plans, PPAP, and statistical process control to ensure timely and successful product launches.
· Prepared and reviewed manufacturing documents required for new program launches.
(BOM’s, Packaging, and Manufacturing Cost)
· Worked with the Quality Dept. to identify non-conforming Charge Air Coolers, through high-level PSI burst/leak tests.
Education
Manufacturing and Industrial Technology (B.S)
Tennessee Technological University College of Engineering-Cookeville, TN May 2009
Bachelor's degree
MBA
University of Phoenix
Skills
• Quality Assurance PLC & CNC
• Precision measurement in machining
• Machining
• Computer skills
• MIG welding
• Computer literacy
• Hand tools
• PowerPoint, and Excel.
• Inspection tools
• Industrial equipment troubleshooting
• Equipment repair
• PDM
• Microsoft Word
• Machines I worked with: Gleason, Cincinnati, and EMAG
• ISO 9001
• Productivity software
• UDI
• AS-400
• LEAN
• Attention to detail
• Manufacturing facility
• Proficient in Auto CAD
• Fabrication
• CNC
• Hydraulics
• and Manufacturing
• Grinders
• Metallurgy & Heat treatment Metal Casting
• Industrial maintenance
• Assembly
• GMP
• HVAC
• OSHA, and GD&T.
• Root Cause Analysis
• Microsoft Office
• Professional (QE) Skills: Gage Instructions, FARO Arm, Minitab, PFMEA & Control
• FDA, and EPA.
• Plans
• EU MDR
• 21 CFR 820 Part 11
• Design Materials for Manufacturing
• GD&T
• Manufacturing company experience
• Manufacturing engineering
• TS16949.
• Maintenance, repair and operations (MRO)
• Relevant Coursework:
• SAP
• V C++ Programming for Engineering Methods
• Welding Technology Design
• Turning
• Statistical Process Control
• Coordinate measuring machine
• Mechanical troubleshooting
• Microsoft Visio
• VSM
• ISO 13485
Languages
• English
Certifications and Licenses
Driver's License
Welding Certification
Six Sigma Black Belt
Six Sigma Green Belt
Six Sigma Certification
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