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Manufacturing Engineer Resume

SUMMARY

  • 5+ years of experience in Test Method Validation (TMV), Process Validations, DHF remediation, and CAPA.
  • Experienced in TMV including attribute and variable methods using Gage R&R analysis.
  • Worked with R&D team during D&D, V&V phase of a new product and developing a new test method for testing.
  • Experienced in developing manufacturing processes for medicalcomponents manufacturing.
  • Reviewed and documented DHF files including Design and Development plan, Design Input, Design Output, Design transfer, Verification & Validation plan, and Risk Management.
  • Worked on DHF Remediation of medical devices and updating PFMEA, routers, BOM, and SOPs.
  • Experience in Investigating and resolving work - in-process problems by using root cause analysis.
  • Assisted development engineers in designing and creating fixtures.
  • Experienced in writing Protocols, Final reports, rationales and other documents.
  • Initiated CAPA and Remediation Activities for different types of medical device documents.
  • Experienced in carrying out problem solving techniques including Lean/Six Sigma statistical tools as Minitab.
  • Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, and SPC analysis.
  • Experience of Production Part Approval Process (PPAP) and Advanced product quality planning (APQP).
  • Strong analytical and problem solving skills and ability to work independently or with cross functional teams.
  • Experience in Computer Aided Design (CAD) and Additive Manufacturing (3D Printing, Selective Laser Melting).
  • Hand on experience in SolidWorks, CREO, Pro-E, ANSYS, STAR-CCM+, HyperMesh, and AutoCAD.
  • Understanding ofmedicaldevice (21CFR 820 & ISO13485) regulatory standards and engineering applications.
  • Knowledge of ISO, ASTM Standards and GD&T Techniques.
  • Experience with medical device compliance requirements based on FDA Quality Systems Regulations.
  • Proficient in MS Excel and other MS office tools.

TECHNICAL SKILLS

Technical Skills: TMV and IQ/OQ/PQ Validations, Lean/Six Sigma, DFMEA, PFMEA, Root Cause Analysis, DHF remediation, Corrective Action and Preventive Action (CAPA).

Designing Skills: SolidWorks, CREO, Pro-E, ANSYS, STAR-CCM+, HyperMesh, AutoCAD

Data Analysis Tools: Excel, Minitab

PROFESSIONAL EXPERIENCE

Manufacturing Engineer

Confidential

Responsibilities:

  • Experience in validation Installation/Operation/Performance Qualifications (IQ/OQ/PQ) for equipment used in manufacturing of medical devices.
  • Prepared multiple test protocols and experienced defining the test parameters for DOE.
  • Created protocol and summary report of Test Method Validation (TMV) for various inspecting methods.
  • Analyzed the collected data using statistical tools as Minitab.
  • Developed mechanical test and validation documentation of new and existing products.
  • Experience in Failure Mode Effects Analysis (FMEA), Risk Analysis, and Master Validation Plan (MVP).
  • Coordinate efforts during investigations, validation deviations, and CAPAs.
  • Participated in CAPA meetings and activities, helped to identify the root causes of the manufacturing problems.
  • Conducting weekly design reviews with the manufacturing and the cross-functional teams solving gaps in the remediated documents relevant to specific Design History Files (DHF).
  • Work with cross functional teams to develop implementation strategies to create the DHF for the medical devices.
  • Perform searches, generate reports, and analyzecontrol charts and datatrendsusing Minitab, TipQA and Enovia forNon Conformance Report (NCR) systems.
  • Developed and maintained Requirement Traceability Matrix (RTM).
  • Researched and developed DFMEA and risk analysis documents for medical devices.
  • Experience with root cause analysis and some risk assessment tools (DMAIC, fishbone) via investigative work.
  • Regular interaction in overseeing manufacturing processes,, inspections and continuous improvement projects.
  • Helped to develop the tests to validate the device, and performed experimental design by testing with non-fielded products while designing test systems.
  • Worked with Product Development team to develop sterilization validation and /or biocompatibility protocols and ensure reports are documented accurately.
  • Develop adequate sampling plans, inspection procedures, and test methods to maintain product performance and meet long term manufacturing goals (yield/scrap, acceptance sampling, etc.).
  • Develop and maintain new products validation plans based upon internal and client SOPs.
  • Worked with the other engineers on process improvement projects to enhance and maintain high standards.
  • Assisted R&D engineers to support implementation of new products by reviewing quality and validation plans.
  • Using six sigma principals identified key process indicators and developed dashboards to illustrate the KPIs.
  • Maintained positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Process/Quality Engineer

Confidential

Responsibilities:

  • Performed Statistical Analysis such as tolerance intervals, process capability and DOE.
  • Conducted and reviewed Installation Qualifications (IQ) and Operational Qualifications (OQ).
  • Developed IQ/PQ protocols and IQ/PQ reports.
  • Developed and executed process validation protocols, attribute and variable Test Method Validation (TMV).
  • Repeatability and Reproducibility (R&R) studies on methods were used for testing medical products.
  • Involved in designing test fixtures for performing Test Method Validation on medical devices.
  • Involved in performing Gap Analysis and preparing the Remediation plan.
  • Remediation Activities including writing Validation Plans, Risk assessment, DOE, Process Validation, Test Method Validation, assisting with s protocols and writing validation summary reports.
  • Worked with Validation engineers for all functional and interface test methods for medical devices.
  • Performed DFMEA and PFMEA analysis and updated required documents.
  • Assisted engineers in CAPA and existing RM Plans and suggested Remediation activities.
  • Identified the potential Hazards in the device and addressed them in the Risk Management Plan.
  • Created work instructions for the operators and updated existing operating procedures.
  • Conducted product testing, creates models, and prototypes, and provided feedback to design engineers.
  • Participated in improvements activities and applying lean and six sigma methodologies.
  • Led all continuous improvement techniques including: Lean Manufacturing Principles, S.P.C., and Kaizen Blitz events, which resulted in increase in the throughput, decrease in labor costs, and improved safety.
  • Monitored, measured and reported manufacturing performance and developed new techniques to reduce losses and improve quality.
  • Recommended and implemented changes to product or process which would improve cost, delivery, and quality for the customer.

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