Profile for Christian U. Mbanefo. BS, MS.

Contact: ac0lfc@r.postjobfree.com, Mobile 612-***-****

LinkedIn: http://www.linkedin.com/in/christianmbanefo6123867861

Immense hands-on experience of Reliability Engineer improvement methodologies that spans job shops, casting foundries, injection molding, aircraft turbo jet components, medical device manufacturing; heart valves, orthopedic implants, balloon catheters / coated balloon catheter, stents, steerable catheters, and dilators, transseptal needle, steerable catheters.

Self-Starter and fast learner with market focused successful leadership in engineering, business, management, and sales that will contribute to the overall success of any organization.

Implemented Reliability Engineer principles and methodologies to increase yield and reduce scrap.

Proficient understanding and implementation of ideas, implementing and improving Reliability Engineer systems, and best practices such as ISO 13485 and 21 CFR, Part 820, familiar with 21 CFR Subpart B Part 4, ISO 14971, Use DFMEA, PFMEA FMEA, CAPA’s, Lean and Six Sigma mythologies, FDA-GMP, ISO 9000, TQM, Minitab, solidWorks various business software.

Diverse and flexible with people and tasks. Amongst my assets is my people skill, I value my ability to I listen, investigate, and understand what is/are the challenges.

Ability to follow through with a logical pattern to find solutions and provide leadership and direction for personnel to ensure delivery of Reliability Engineer solutions.

Energetic and pragmatic when dealing with people and challenges. Included in my core competencies are organizational, high-level problem solving, quantitative, qualitative analysis, and strong systems applications skills.

Inspired shared enthusiastic commitments that lead team members to accomplish project goals on time.

Self- starter, with the ability to work independently and with all levels of managers, associates, and clients.

Lead by example and ensured the execution of all Design Assurance revisions that translated into manufacturing operations policies, procedures and Work Instructions (SOP’s)

Post Market Surveillance review and recommendation.

SKILLS

Background in Engineering

Reliability Engineer objective and goals execution

Project Management

Resource Management

New product design delivery - R&D to production

Teambuilding & Supervision

Design Assurance methodologies

Reliability Engineer Assurance Risk Mitigation and Management

Reliability Engineer Assurance Product line expansion

Reliability Engineer Assurance implementation and management of methodologies

Reliability Engineer Process improvement

Small business development

International Contracts Negotiations

Supply Chain Management

Global Sales & Marketing

Leadership and communication skills

Sales & Margin Improvement

Small Business, and Financial industry

Recruiting, Training & Retention

Professional Background:

QA/RA Consultant, (2+ months Contract August to October)

Hill-Rom (Respiratory Care)

St. Paul, MN.

Read 3500 complaints and group the complaints into six categories and made recommendations.

Initiated a Non product Software OQ, IO and PQ validation

Provided guidance to teams regarding application of supplier reliability procedures.

Agile evaluation of supplier performance management, supplier certification, process improvement, and cost reduction, supplier.

Assisted performing trending and review of supplier-related reliability data in Agile.

Participated in root cause / failure analysis of supplier-caused non-conforming product, and ensure product Reliability Engineer concerns are adequately addressed by the supplier.

Assisted with the rationale in decision-making activities to drive Reliability Engineer to assure nonconformance trending, CAPA effectiveness, part qualification, process monitoring.

Interfaced with supplier’s engineering and management teams to ensure that corrective & preventive action is implemented in timely manner and is effective to prevent recurrence.

Measured and communicated supplier performance on key reliability metrics and project milestones and uploaded into Agile.

Assisted in internal Corrective Action and Preventive Action (CAPA) activities.

QA- Risk Management Consultant, SME (4 months contract extended 10 months)

Depuy Synthes a Johnsons and Johnson Family of Companies

Monument, Co.

August 2015 to April 2016

Demonstrated knowledge of, regulatory and Reliability engineering policies, principles and best practices

Applied in-depth knowledge of product risk management use standards and tools (e.g. ISO14971:2012, 21CFR820, e.g. PRA, SHA, SFMA, DFMEA,PFMEA and created required documents

Proven track record of initiating and driving continuous improvements efforts and working knowledge of problem solving methodologies (DMAIC, Six Sigma, etc.)

Working knowledge of Reliability Engineer Engineering and medical device regulations (FDA 21CFR820, ISO13485), Reviewed documents related to 21 CFR Subpart B Part 4

Applied mastery of medical device Reliability Engineer systems and applications to perform Risk Assessment.

Mastery and use of software programs - Microsoft Word, PowerPoint, Excel, Outlook, Project, and Minitab.

Used of product lifecycle management (PLM) softwares - Windchill, DocuSphere, CDR (Common Document Repository) Sto perform system searches to complete internal audit and Gap Analysis.

Demonstrated ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives.

Broad business knowledge and ability to link Vendor needs with J&J business needs.

Remedial Project Engineer (Contract Positon 6 months required by Medtronic).

Sil-Pro LLC, Delano, MN, 01/2014 to 9/2014

Developed master remedial plans for 9 components of Sil-Pro LLC legacy products manufactured for Medtronic's diabetes division and completed the necessary documentation.

Reviewed and critiqued business and functional requirements for Reliability Engineer assurance needs on components – eliminate wasteful tasks and actions.

Performed tolerance analysis using SolidWorks, identified critical feature, functional criteria on prints and components.

Used SolidWorks to perform gap analysis and tolerance verification on prints.

Identified Silicone requirements and established Key Performance Indicators for incoming material Reliability Engineer Assurance.

Started Trial runs on legacy parameters, designed and implemented new test fixtures. Design Validation Testing (DVT), including Test Method Validation (TMV)

Established process controls (Control Plans) based on component risk Level.

Reviewed and implemented all supplier changes through Medtronic Process Change Notification (PCN) system, including but not limited to design changes, due to new molds and manufacturing changes.

Applied the use of statistics, including but not limited to sample size selection, data distribution analysis, capability calculations, ANOVA, Design Of Experiments (DOE), and Analysis of Variation to determine parameters "Minitab" an implemented changes.

Conducted and/or participated in risk management activities, including process FMEA and design FMEA.

Conducted and documented root-cause analysis of component failures identified during validation, qualification and production. Issued Corrective And Preventative Actions (CAPA) internal or external as appropriate.

Performed pre-qualification and trained technicians on first article inspection activities and associated Reliability Engineer system reports.

Performed Process Verification and Validation, including Validation Master Planning, Installation, Operational and Performance (IQ/OQ/PQ) Qualification

Analyzed critical dimensions with target CPK > 1.33, provided changes to Medtronic’s and documented evidence that work was accurately performed.

Consultant/General Manager

Clear Science Inc. Minneapolis, MN, 11/08 to 2013

Met with President and Scientists inquired how the company operates to create a plan.

Summarized in writing and communicated the recommendations for business improvement.

Reviewing financial statements evaluating competitors and analyzing business practices for additional improvements.

Developed a new business model and prepared recommendations presented to the President.

Drafted and completed the Submission of SBA loan.

Modeled and provided forecast for future growth. Documented and managed weekly and monthly P&L.

Negotiated and developed customers base for added valued and improved sales.

Engaged in New Business Development activities to increase sales. Structured, developed, and managed Google Advertisement campaign, searchable applicable keywords.

Performed as needed ongoing, managerial, and consulting services.

Sr. Design Assurance Engineer (Biosense Webster Project)

Greatbatch Inc., (4 months contract extended to 7 months) 11/2010 to 6/2011

Focused on design related project activities and deliverables as required by the Product Development Process (PDP)

Developed, analyzed and validated test methods per PDP, in conference with technicians, R&D, Process, and Manufacturing engineers.

Formalized test Methods and parameters using Reliability Engineer methodologies

Provided Reliability Engineer assurance support to new product development team, reviewed component prints and performed tolerance analysis. Recommended and agreed on appropriate changes.

Mentored and trained technicians on application Reliability Engineer measurement tools and methods.

Supported and created design control activities (e.g. Characterization, Process Validation, specification analysis, and justification, reviewed Process, Receiving Inspection instruction and Product Validation, Design Validation Test (DVT), Test Method Validation (TMV).

Assisted in qualifying component suppliers as needed, issued Corrective And Preventative Actions (CAPA) when appropriate.

Established functional tolerance variability reduction, Used Minitab for ANOVA, DOE, Gage R&R, SolidWorks, use of Six Pack for component analysis

Reviewed and supported clinical customer complaint analysis, and recommended guidance to Regulatory Affairs.

Served as Reliability Engineer Design Assurance member that created, reviewed and documented DHF,DFMEA, PFMEA, issued Corrective And Preventative Actions (CAPA) when appropriate.

Initiated Use FMEA for IFU. Wrote or reviewed validation protocols.

Provided support for assurance deliverables as defined by PDP – Wrote Reliability Engineer Plan, Vendor Component list, Vendor Qualification, Reliability Engineer Report, Post Market Surveillance Reliability Engineer Plan and Report, Final Reliability Engineer Report that documented Risk mitigation results and action items.

Wrote or reviewed and supported R&D, Regulatory Affairs submission, PD Manufacturing IQ/OQ/PQ. Created or reviewed design controls.

Analyzed design capability metrics to assure design robustness.

Worked with project team to assure appropriate Reliability Engineer and reliability requirements as defined.

Advisor

OneAmerica, 1/06 to 11/09.

Assessed and documented the investor's circumstances and needs. Determined the investor's risk and return objectives.

Established the risk level that investor is willing to assume in accordance to the desired level of return.

Determined the need for liquidity and the time horizon of the investor to start drawing from investments.

Established other expenses that investor may have that will significantly impact financial commitments until retirement.

Created a Financial Plan that reflects risk and return are directly proportional to ensure that investor's willingness and the ability to assume risks complement each other.

In case of any imbalance, clearly illustrated the risks and the benefits of assuming the given level of risk prior to allocating investment into specific assets.

Devised highly individualized strategies aimed at wealth creation and capital preservation.

Actively engaged in new business development to increase sales of financial products

Financial Advisor, Supervisor, District Manager

Waddell and Reed Inc., 1/00 to 11/06.

Managed the responsibility of all aspects of a district office’s operations – budgets scheduling, seminars, and visits to companies.

Settled investor complaints that have escalated beyond the financial advisors scope of function.

Adjudicated disputes between financial advisors, especially in situations when multiple financial advisors attempt to prospect the same potential investor.

Hired, trained (three classes a week i.e. Products, Prospecting, and Distinctive Sales Techniques, Financial Planning, Branding), mentored, and performed field calls with new advisors.

Responsibility for assessing the investor's circumstances and needs prior to creating a plan.

Determined the investor's risk and return objectives need.

Established the risk that the investor is willing to assume with the desired level of return.

Determined the need for liquidity and the time horizon of investor to accumulate and retire.

Established other expenses that the investor may have that will significantly impact financial commitments until retirement.

Created Financial Plans that the risk and return are directly proportional to ensure that investor's willingness and ability to assume risks complements each other.

In case of any imbalance, clearly illustrated the risks and the benefits of assuming the given level of risk.

Devised individualized strategies aimed at wealth creation and capital preservation.

Actively engaged in new business development to increase sales of financial products – cold calling.

President and Founder,

M Syndicate Inc. Otsego, MN 10/1994 - 11/1999

Researched and developed business plan to secure additional start-up funds. Started the implementation research.

Traveled to Argentina, Ecuador, Chile, Columbia, Peru and Venezuela to meet with prospective representatives and distributors at the US Commercial Embassy desks.

Designed and implemented a three-tier marketing survey to narrow the selection distributors out of 75 companies from various countries.

Learning legal gymnastics understanding international accounts payable and accounts receivables.

Completed outstanding product orders for Ecuador, Peru and Chile in 1998.

Identified 7 sales distributors in 4 Latin American countries that became revenue producers.

Actualized international sales from $0 to $1.350 million.

Designed and implemented catalogs, sales promotions brochures and ever-changing price list for a fast pace personal computer, computer server environment.

Consultant and general contractor for Devax Inc., Edina, MN to design and implement telephone system, desktops, and LAN and Web hosting.

Consultant and general contractor for Angioguard Inc., Plymouth, MN to design and implement telephone system, desktops, and LAN and Web hosting

QA Engineer, Sr. QA Engineer, QA Engineering Supervisor, Project Engineer,

SciMed Life Systems Inc. Now Boston Scientific Inc. Maple Grove, MN 10/88 to 11/94

Reliability Engineer Engineer on the Team that lead the implementation for ISO 9000 company-wide

Responsible, coached and mentored 3 junior Reliability Engineer Engineers and 4 Technicians that worked on NPD (New Product Development).

Assigned, monitored and updated tasks to report back to senior management.

Reliability Engineer Assurance Engineer on NPD engineers that consulted with Medical Advisory Board to determine product requirements and effective use during product development.

Traveled to clinical trial facilities to assess and analyze product Reliability Engineer/performance or functional issues in order to assure and implement corrective performance measures.

Effectively lead, coordinated the function of Reliability Engineer Action Team prior to transfer of products into production. Increase product yield prior to final release using statistical Reliability Engineer methodologies.

NPD Project Engineer for the development of Balloon Catheter with Hydrophilic polymers

Lead Reliability Engineer Assurance Engineer that acted on analyzing Reliability Engineer issues reported by customer and implemented permanent resolutions that will avert re-occurrence.

Designed and Implemented test protocols, ASTM standards and sampling plans.

Lead and supported development and implementation of product Reliability Engineer reporting system using statistical methods. Orchestrated and supported the development and implementation of prevention based Reliability Engineer controls the created reasoned results.

Responsible for the manufacturing and process development of Hydrophilic coating from R&D to production

Responsible for the implementation of the tungsten loaded polyurethane guide wire product family into production

Lead effective short term containment and permanent corrective actions using DOE, SPC and the Reliability Engineer tools.

Facilitated cross functional Reliability Engineer teams to improve product acceptance levels using root cause analysis and problem solving tools.

Lead supplier selection, compliance and audit procedures on new and existing products and responsible for supplier corrective actions to exceed internal targets for component Reliability Engineer.

Developed and implemented procedures and processes for receiving inspection and first article inspection.

Responsible for Material Review of Nonconforming Material in-house and purchased products to correctly disposition, follow-up with suppliers, evaluated performance and feedback.

Acted as the liaison between Product Manager, Product Distribution sites, Product Engineering, and Sales to support root cause analysis and develop short-term containment and permanent solutions to filed issues.

Ensured compliance with Reliability Engineer Management system (applicable ISO or internal standards)

Die Casting Inspector

Minnesota Rubber, New Hope, MN 8/88 to 10/88

Ensured and approved that First Article Inspections, (FAIs).

Lead team to performed FAIs and monitored inspectors for two shifts. .

Inspected products, and equipment to determine defects and implement corrections.

Generated Non-Conforming Reports, (NCRs), notified product engineers.

Reliability Engineer Assistant / Control Inspector, Technical Specialist,

CarboMedics / InterMedics Orthopedics, Austin, TX 5/84 to 8/88

Ensured and approved that First Article Inspections, (FAIs) are performed prior to CNC machining of components or recommended adjustments prior to run.

Lead team that performed FAIs and monitored inspectors for two shifts.

Assured that floor Inspectors are monitoring all work stations as basis and results are reported back to the machinist.

Inspected products, and equipment to determine defects and implement corrections.

Generated Non-Conforming Reports, (NCRs), notified product engineers of production errors and possible resolution.

Maintained the calibration and traceability of gages and other inspection equipment i.e. CMM, Optical Comparator, NDT (X-Ray) and Hand tools requirement of accuracy of +/- .0005 and repeatability of +/- .0005

Acted on behalf of final Assembly to audit and maintain the accuracy and timely delivery.

Machine Shop and Quality Control Supervisor

Preferred Stamping Texas, Inc. Round Rock, TX, /84 to /84

Duties included but were not limited to the development and implementation of a Reliability Engineer control system. Job routing from customer prints.

Responsible for the development of manufacturing and inspection processes.

Development and Implementation Statistical Reliability Engineer Control for manufacturing processes

Education:

Argosy University, Twin Cities Campus MN 9/07 to TBD

Earned 12 Doctorial credits; concentration in Business/Higher Education studies

Cardinal Stritch University, Milwaukee, WI, 8/03

MS Business Management

University of Northern Iowa, Cedar Falls, IA, 5/84

BS – Manufacturing / Industrial Design

Marshalltown Community College, Marshalltown, IA, 5/82

AAS – Pre - Engineering

FINRA General Securities licenses Series 7 and 66 1/00 to 4/11,

Member SME, and ASQC

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