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Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Professional Summary

Manufacturing Engineer with over 3 years of diversified design, manufacturing, quality and process engineering experience in high and low volume production. Extensive background in Medical, Pharmaceutical and automotive engineering. Aggressive at identifying and resolving inefficient procedures and processes.

Skills
  • Minitab
  • MSA, GD&T and SPC
  • Design Controls
  • GMPs, WCM and GDP
  • QSR (21 CFR 820)
  • MDD 93/42/EEC
  • ISO13485 and ISO14971
  • EUMDR
  • IATF 16949
  • ISO 9000
  • Quality Control
  • Cost and Time analysis, Break Even Analysis.
  • Operations Management
  • PPAP, APQP and DMAIC
  • New product introduction/development(NPI/NPD)
  • Design and Process Failure modes effects and analysis(DFMEA/PFMEA)
  • Process Flow Diagram(PFD)
  • Auto CAD, Solid Works and Creo
  • Problem Solving, FAIs and Incoming Inspection
  • MS Office, Excel and VBA
  • 8D, 5 Whys, Is-Is not chart and A3
  • Validation activities, TMVs and process capability
  • Product development
  • Project Management
  • Critical thinking
  • Change Management, Windchill and Agile
Education
Wayne State University Detroit, MI Expected in 05/2018 Master of Science : Industrial Engineering - GPA :
Jawharlal Nehru Technological University Hyderabad, India, Expected in 05/2015 Bachelor of Science : Mechanical Engineering - GPA :
Work History
Tenneco Automotive - Manufacturing Engineer
Meuspath, DE, 08/2020 - Current
  • Coordinated all aspects of production, including selection of manufacturing methods, fabrication and operation of product designs.
  • Provided engineering expertise for manufacturing operations to ensure products are produced at optimum costs, at all times, in order to insure customer satisfaction.
  • Provided accurate assembly methods, process instructions, routings and standards.
  • Reviewed manufacturing processes for gaps and provided effective solutions in inefficient areas doing a gap analysis.
  • Assisted in development of leak testing systems, including automated leak testing equipment.
  • Created necessary Layout changes for operations to run the lines efficiently during Covid.
  • Assisted in developing capital expenses for NPI and kaizen activities by working with project engineering team.
  • Created and maintained Process Flow, PFMEA for new product introductions (NPI).
  • Worked with planning team to assist in BOM development for assembly line and sub assembly lines.
  • Created and routed the documents for NPI or engineering changes using Windchill.
  • Executed and supported Alpha, Beta, Pilot production plans and execution for 3 NPDs on the assembly lines.
  • Updated and trained End of Line testers as necessary for NPIs and engineering changes by working with Quality and Training department.
  • Conducted time studies(MODAPTS, Gemba analysis) on assembly and sub assembly processes to standardize the processes.
  • Updated Standard Work, Work Instructions and Playbooks based on the time study reports.
  • Trained shop floor manufacturing engineers and quality associates on NPI/NPD.
  • Daily shop floor support for troubleshooting assembly issues on the lines.
  • Analyzed torque requirements of new products on line to determine feasibility of design.
Danaher - Manufacturing Process Engineer
New Brighton, MN, 09/2019 - 08/2020
  • Applied project management metrics and tools in oversight of engineering and manufacturing projects and program services.
  • Researched and tested design feasibility and operation of equipment, components and systems.
  • Used automated downtime tracking to rapidly design, optimize and reverse engineer optimal cost production lines, factory operations and supply chain interactions to run and operate with maximum autonomous and semi-autonomous throughput.
  • Created Work instructions (WIs) and standard operating procedures (SOPs) to support the line launches.
  • Trained the operators and technicians on line to WIs and SOPs.
  • Worked with customer engineering and site automation engineering team to develop new processes, Kaizen & continuous Improvement activities.
  • Designed factory and production line layouts for maximum throughput for the space provided by working industrial engineer and Plant Manager.
  • Designed and developed cutting edge automation equipment.
  • Documented detailing requirements and specifications
  • Managed the design, vendor selection and development of production lines, automation cells and production equipment from concept to commissioning.
  • Worked cross functionally with all disciplines involved in specifying and engineering complex mechatronics products by developing and defining KPIs.
  • Lead and contribute during all phases of the project from initial concept(IQ,OQ and PQ) to production ramp-up.
  • Lead all New product validation activities and documented the reports.
  • Reviewed all documents to be in complaint with GDP, ISO 13487, FDA and cGmp requirements.
  • Created and maintained PFD, PFMEA and Control Plan.
  • Worked in agile environment to update the engineering changes and BOM activities.
  • Worked with quality engineering to help in investigating and closing the CAPAs.
Blue Origin - Design Quality Engineer
Merritt Island, FL, 02/2019 - 09/2019
  • Worked with R&D, Program manager and advance manufacturing engineering team on timely and accurate completion of 12 Catheter projects.
  • Provided leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
  • Communicated effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.
  • Developed training protocols in alignment with company quality, FDA, ISO 13487, EUMDR and 14971 regulations.
  • Performed quality inspections and drafted reports to detail non-conforming material issues.
  • As Senior Quality Engineer, provided input to our NPI processes and design teams in the design and development of highly complex medical devices.
  • Quality lead for 12 New Product developments, including tooling confirmations, FAI (First Article Inspection), DHR reviews, FMEAs, DFMs, supplier management activities, NCs and CAPAs.
  • Contributed to root cause analysis to determine root cause using 8D, 5 whys and A3 reports working with product development team.
  • Utilized knowledge of FDA, ISO 13487, EUMDR and IS0 14971 standards to develop action plans for company certification during audits.
  • Coordinated with quality control staff to complete inspections.
  • Provided support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
  • Reviewed and approved design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
  • Supported risk management activities including planning, design &clinical risk management DFMEA, production risk management PFMEA,and overall risk summary reporting.
  • Revised, reviewed and approved verification and validation activities as required.
  • Reviewed and approved any required drawing updates, including design impact assessments.
  • Reviewed and approved any labeling updates, including design impact assessments.
  • Applied statistical methods and process excellence tools to support design engineering rationales/memos as required.
Aptiv - Project Engineering Intern
Tangier, VA, 10/2018 - 02/2019
  • Acquired knowledge of industry trends and developed solutions and strategy through effective research.
  • Gave presentations of completed work to managers.
  • Answered questions for customers about various aspects of assembly manufacturing equipment(Sheathing).
  • Supported project engineer on various quality documentation like PPAPs,, PFMEAs etc.
  • Inspected assembly equipment before, during and after projects to maintain progression and functionality.
  • Used SAP for closure of corrective actions by updating the documentation for the non-conforming product/process.

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Resume Overview

School Attended

  • Wayne State University
  • Jawharlal Nehru Technological University

Job Titles Held:

  • Manufacturing Engineer
  • Manufacturing Process Engineer
  • Design Quality Engineer
  • Project Engineering Intern

Degrees

  • Master of Science
  • Bachelor of Science

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