Product Development Engineer

Mike Boykin

Quality/Process/Manu/New Product Development/Regulatory

Lee's Summit, MO ********@***.*** - 903-***-****

WORK EXPERIENCE

Sr. Quality Engineer

ZIMMER BIOMET – Warsaw, Indiana – November 2017 to Present

This company produces orthopaedic medical company

•Working with suppliers to meet deadlines for labeling changes to satisfy US and International guidelines concerning UDI labeling.

•Monitoring PPAP documentation pressing vendors concerning quality documentation and validations leading to First articles development and inspection.

•Validating new suppliers to compensate for inadequate vendors.

•Documenting, updating and changing drawings to justify customer needs.

•Tracking updates on vendors concerning gap analysis of quality issues.

•Working with cross-functional groups to understand quality issues, CAPA, and warrants for finished products.

•Working with 21 CFR Part 820, ISO 9001, and ISO 13485

Quality/ Process Engineer

EAGLE-PICHER – Joplin, MO – January 2017 to October 2017

This company produces medical, military and Space & Technology batteries.

•Developing and validating manufacturing processes on medical, Space & Technology and military battery applications. Product and process development entails using Minitab to calculate CpK and Ppk values to justify processes as normally distributed.

•Managing process improvement projects coordinating with plant personnel and outside suppliers on medical and Space projects.

•Providing technical support as required.

•Working with 21 CFR Part 820, ISO 9001, and ISO 13485

•Through hands on development, develop reaction plans to prevent non-conforming product

•Reviewing existing processes, and process controls, Completing DFMEAs, PFMEAs, Design History Files, IQ/OQ/PQ/PPQ, and SOPs for new, existing, and sustaining product lines.

•Assisting vendors and subcontractors in evaluating and troubleshooting development and product concerns.

•Training and mentoring engineers in Quality, Manufacturing, Process, Validation, Regulatory, and Continuous Improvement.

Senior Mechanical Engineer (Quality), Purchased Products, Plastics

HONEYWELL FM&T - Kansas City, MO - August 2011 to November 2016

•Working with Design Agencies to provide engineering concepts and information to complete critical path to solutions. Lead technical execution of yield, quality, and manufacturability product improvements. Yearly achieving $5 million cost savings.

•Partner with Supply Chain and AME team to develop production build plan for all raw materials and finished goods in order to achieve Time to Market (TTM) and Time to Ramp (TTR) targets Established knowledge of customer, products, technologies and processes. Provides operations input for supplier selection and process development activities.

•Maintain global awareness of manufacturing strategies & capabilities and provide insights into technology specialties across the global manufacturing sites to project core teams.

•Work directly with vendors to determine product specifications and arrange for purchase of capital equipment, tooling, materials or parts, and evaluates products according to specifications and quality standards. Tests and validates newly installed machinery and equipment to insure fulfillment of contract agreements. • Advise management of developments which may affect profit, schedule and costs using TIER Boards.

•Communicate and coordinate project activities with multiple functional groups both within and outside of operations.

•Analyzing and interpreting information related to problem solving solutions. Ability to manage multiple initiatives simultaneously

•Working with multiple initiatives simultaneously.

•Drive application of Six Sigma and GREEN BELT solutions for product improvements.

•Taking complex engineering concepts and creating innovative and cost structured solutions, especially concerning technical forecasting. Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.

•Support process verification and validation testing activities.

•Assist with selection and qualification of new materials and suppliers.

Program Manager (Contract)

SYNTEL, INC - Troy, MI - November 2009 to August 2011

This company assists in executing product development, regulatory, and manufacturing related duties or projects for other companies, as well as to contracts and consultants. Use of Six Sigma and Black Belt Tools to establish product and manufacturability solutions.

•Working for Johnson & Johnson in engineering process, manufacturing, and product development saved over $2 million on product design and manufacturing refinements.

•Transferred significant product lines to plant in Ireland., Class II and Class III.

•Working on New Product Development using PPAP and New Product Development Quality Manuals writing SOPs and performing validation testing.

•Established cost cutting improvement program in Juarez, Mexico creating over $5 million in cost savings.

•Worked with R&D, Sustaining Engineering, Purchasing, Program Management, and Marketing participating in new product development to insure new product design has efficient production methods.

•Helped startups create program charters to get grants and seed money.

•Completed product and process development projects completing four product lines. Managed programs from charter through execution and closing

•Worked with global companies generating production and manufacturing work in the United States. Increased over 30 positions between two separate companies.

Staff Engineer, (Contract)

MEDTRONIC - Fort Worth, TX - September 2007 to October 2009

Pioneer and leader in powered surgical systems used in bone surgeries, mainly drills and saws used in head and back surgeries.

•Responsible for creating and developing three electric surgical micro-saws and a complete saw blade product line to compete with market share leaders using two Medtronic facilities with different cultures and different product development policies using Lean Product Development.

•Working directly with marketing and surgeons developing laparoscopic, endoscopic, electrosurgical, and pneumatic products determining Voice of Customer by viewing patient surgery and cadaver discovery labs. Increased sales of mature product line by 20% in one year. Created program charter to foster interest in updating this product line.

•Performed Process and Product Validation process for FDA submissions and ISO requirements.

•Working to overcome infection control issues from bone and bone dust collection during operations while fusing grafts. Created project charter to drive management to fund this project area.

•Working with engineering groups on ISO issues for world-wide approvals using FDA Design Controls, (ISO9003, ISO 13485 and TGA).

•Receiving three patents for saw blades and collet configurations for surgical instruments.

•Engaged two facilities in product development pushing engineering groups to complete and launch a product-line previously stalled in process engineering by driving the program from initial charter through execution of program scope.

VP of New Product Development and RA/QA

CARDIOVASCULAR INNOVATIONS - Athens, TX - April 1996 to September 2007

Startup Company engaged in angiography techniques used in cardiology for diagnostics and invasive techniques identifying heart issues in arteries. Expanded business with five engineers as a technical medical consulting group dealing with product development for Fortune 100 and 500 companies.

•Responsible for all daily aspects of the company. Developed programs with numerous companies to charter programs in cardiology techniques and processes.

•Developed a disposable contrast delivery mechanism to ease in use of contrast delivery during cardiology and cardiovascular procedures with FDA approval and ISO Certification (OZ Power Syringe).

•Developed of a process whereby Teflon coating is applied to a wire and then built into various guidewires.

•Worked with numerous companies and doctors from brainstorming through development concerning cardiology, infection control, cardiovascular issues, critical care, general surgery and cancer procedures.

Staff Engineer

MAXXIM MEDICAL - Athens, TX - February 1994 to April 1996

Cardiovascular and cardiology business specializing in diagnostic techniques for heart procedures.

•Responsible for specialized projects suggested from marketing and clinical experts to evaluate for feasibility through sale of product.

•Developed of a process whereby Teflon coating is applied to a wire and then built into various guidewires.

Product Development Engineer

3M SARNS - Ann Arbor, MI - February 1991 to February 1994 in Cardio-Thoracic products encompassing all disposables and products included in Cardiopulmonary bypass.

Responsible for product development of Cardio-Thoracic Cannula/Catheter medical disposables. Responsible for obtaining product justification and funding. Formulated cross-functional teams through idea phase through start up. Completed all projects in fifty percent of expected time.

•Responsible for product development of Cardio-Thoracic, Cannula/Catheter medical disposables.

•Responsible for obtaining product justification and funding.

•Developed a cannula product line that changed aortic flow during cardiopulmonary bypass. Documented that over one million post-surgical strokes have been avoided because of this product. Received the 3M Championing Award for this project. Product line has generated $150 million in sales.

•Developed a retrograde coronary sinus stylet and catheter to be used during cardiopulmonary bypass.

EDUCATION

Master of Business Administration

Texas A&M - Commerce, TX

Bachelor of Science in Mechanical Engineering

University of Kansas - Lawrence, KS

Bachelor of Arts in Sociology

William Jewell College - Liberty, MO

AWARDS

STARR-Significant Technical Achievement

August 2013

Highest technical achievement award at Honeywell for new product development.

ADDITIONAL INFORMATION

AREAS OF EXPERTISE

Project & Program Management: Completed numerous product development, manufacturing assignments using Voice of Operations (VOO) in New Product Development (NPD). Provide Six Sigma and Lean support through evaluation and improvement of development through sale. Bring industrial engineering skills, to R&D activities related to single use disposable products. Perform a lead role in development to completion of products. Expert in injection products. Continuous focus on improving supplier quality, on-time delivery, supplier selection, new supplier identification, and support supply chain strategies in emerging markets.

Collaborate with critical suppliers ensuring quality requirements are met in both product and process. MBA in business development & program management and twenty plus years of experience in process, manufacturing, and product development engineering. Developed and successfully sold a startup company. Ability to drive projects from concept through completion. Expertise in manufacturing upgrades and taking products from design through launch. Especially good at very fast turnarounds in cost savings areas. Expertise at financial and cost accounting and creating budgets to challenge company profitability. Strong program management skills especially executing projects as scope evolves. Especially apt in establishing new programs and projects.

Product Design: Awarded several utility and design patents, (13). Strong working knowledge of technical matters across a wide range of activities in several Engineering disciplines. Strong ability to evaluate products and design for manufacturability. Develop products using Voice of Customer. Successful in Purchased Products, recently working with Design Agencies in all engineering disciplines Expert in addressing customer issues to quick results. Experience with and high level of understanding of stage-gate product development processes.

Technical / Regulatory Knowledge: Expertise in Design Controls. Wrote entire SOP system for four companies. Completed three FDA audits and two ISO audits individually. Strong knowledge of quality systems, policies, procedures, and ability to apply to supplier requirements

Advanced Product Quality Planning (APQP) process

ISO 13485, ISO 9001, QS 9000, and 21CFR820 requirements

Quality system audits

Green belt techniques: Process Flow Maps, Control Points, pFMEAs and dFMEAs.

Worked on numerous product lines from concept through final product. Extensive Knowledge of ISO regulations. Green Belt and Design for Six Sigma Certified. Known world-wide for ability to work effectively with technical and non-technical personnel. Always work to tight deadlines, meeting goals effectively. Strong self-starter and expect others to accomplish goals along with me.

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