John H. Bode Ph.D., P.Eng., P.E., Cppm, Ust-Cap Email & Phone Number

Saint Paul, Mn, Us

Leader in Product Development Engineering Management.

GLG is a New York based consulting company where I'm a registered consultant in medical product development/design/materials/prototyping/analysis/testing/FDA-ISO environment/etc.

Ham Lake, Mn

Substituted temporarily for the Quality Manager who had a medical emergency - Responsible for providing consulting quality support services:* Quality Assurance, Quality Control, Document Control, Regulatory Affairs, IQ, OQ, GAP Analyses & Remedial Actions, CAPA, etc.

Olympus Surgical Technologies America - OSTA* Product Design Assurance* Application of Human Factors Engineering (HFE) | Usability principles to Medical Devices

Greater Minneapolis-St. Paul Area

As technical project leader, developing testing plan/procedures of Dry Powder Inhalers & Disposable Insulin Injection Pens as well as meeting customer time and cost objectives. Responsible for establishing testing activities, test equipment identification/procurement, data analysis, establishing & maintaining test data base, report writing and contingencies development. Following FDA 21 CFR 820, ISO, ASTM, etc Standards. Developing work instructions for and undertaking the following: Gage R&R studies, Design of Experiments processing, Failure Mode & Effects Analysis, Fishbone Root Cause Analysis, Visual Inspections, Designing & Evaluating Tests, Design Verification Reports, Bio-compatibility Studies, Test Method Validation Protocol development, IQ, OQ & PQ of equipment.

Greater Minneapolis-St. Paul Area

Transferred designs from R&D to international manufacturing facilities while complying with regulatory FDA / EU GMP requirements. Establishing IQ, OQ & PQ protocols for the introduction of new medical product developments as well as providing engineering support to manufacturing. Developing new and reviewing existing dFMEA and pFMEA processes. Undertaking appropriate statistical analyses and Gage R&R studies.Responsible for medical product Design Verification Test (DVT) Protocol and Report generation.

Greater Minneapolis-St. Paul Area

Responsible for test method development, protocol establishment, test method validation/verification, test method execution, test method report documentation and Minitab statistical analyses. All processes are part of IQ, OQ & PQ developments.

Des Moines, Iowa Area

Katecho is an internationally recognized full service original equipment manufacturer (OEM) specializing in medical, dental and cosmetic devices. As Product Design Manager, I am responsible for product designs from initial planning stages through product release, ensuring proper documentation is provided in accordance with quality standards (AAMI specifications, ISO 9001, 13485, FDA design controls and/or similar regulations. I provide hands-on engineering design, leadership and guidance for non-routine problems requiring substantial judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria. I am responsible for the design and transfer to production of disposable medical accessories such as medical electrodes (defibrillation electrode, etc), wound/trauma dressings, pharmaceutical & cosmetic patches as well as products for the dental market.

Providing consulting engineering services.

Minneapolis, Mn

As Product Development Manager I was responsible for providing engineering guidance and support to all product developments as well as well as internal research laboratory functions. Successful in developing new as well as improving existing applications of advanced materials used in medical, food packaging, industrial and military applications. I was granted several US patents that are in current use in the food and medical industries. Additionally, I was granted two new ASTM Testing Standards.

Eagan Mn

As VP of Engineering, achieved multi-million dollar annualized cost reductions through hard tooling and process changes as well as implementation of state-of-the-art design and analysis computational software. Developed and implemented a product design and development methodology to assure that all product developments follow a well -defined and documented design process. Established and managed the engineering department of 20 staff consisting of: design engineers, structural analysts, production engineers, custom product engineers, technical writers & illustrators as well as support personnel.

I established and managed the electro-mechanical design developments of both carriage and drum printers at LaserMaster, a leader in developing high speed, high precision, large scale printers for the fine arts printing industry. I was granted several US patents for incorporating composites as well as modifying boundary layers for improved imaging in the printing process.

Greater Minneapolis-St. Paul Area

As Structural Mechanics Manager, I was responsible for establishing and certifying the integrity of numerous Department of Defense land, sea and air fielded ordnances. I developed and managed Honeywell's/Alliant Techsystems' (ATK) multi-million dollar composite material research programs (IR&D) consisting of universities, in-house, industry and DoD participants.

Houston Texas

Calculated impact energy releases and undertook damage assessments of offshore platforms struck by various tanker bow configurations. Managed on behalf of Exxon: international, multi-million dollar research programs investigating the effects of offshore environments on bottom founded reinforced concrete gravity structures. Developed computer software that incorporated dynamics, solid mechanics, energy loss and fluid mechanics. This code was developed for undertaking structural analyses of offshore platforms subjected to ocean currents and waves.

Six Sigma Yellow Belt Certification

Master Of Business Administration - Mmba Program

Doctor Of Philosophy (Phd), Mechanical Engineering - Engineering Mechanics

Activities and Societies: Sigma Xi | New York Academy of Sciences | Sigma Rho | ASME

Master Of Science (Ms), Engineering Mechanics

Activities and Societies: Tau Beta Pi | Pi Tau Sigma

Bachelor Of Science (Bs), Aeronautical And Astronautical Engineering

Activities and Societies: American Rocket Society | American Institute of Aeronautics and Astronautics | Physics & Chemistry Lab. Instructor

Certified Professional Program Manager - Cppm

Certified Agile Practitioner, Ust-Cap, Agile Project Management