Resume

Sign in

Design Engineer

Location:
Kenosha, Wisconsin, United States
Salary:
120,000
Posted:
January 31, 2017

Contact this candidate

EXPERIENCE

Technical

Product Development Management of teams, schedules, and budgets focused on cooperation and planning

Material selection and fitness for use assessment. GMP compliance including CAPA, DHF and DMR’s

Process design, tooling design, life testing, Electro-Mechanical System design, statistical analysis with skill in setting up quality assurance programs

Solved persistent problems with curve fits, spreadsheets, and engineering, bringing control and understanding to areas of high scrap, poor quality and confusion

Experience with MS Project or other scheduling tools where required

Proficient in AutoCAD and SolidWorks 3D design

Resolve problems with data analysis tools like Minitab and Excel

Extensive machine shop experience, including equipment integrating PLC and Arduino controllers

Sterile packaging expertise

Knowledgeable with extrusion, molding and forming of thermosets and thermoplastic materials

Experienced with the Patent Application Process

I am the inventor on over a dozen patents and patents pending

Experience ranges from construction to disposable medical products, from material selection for biocompatibility to beam load calculations and code compliance

Management

Program Management with a record of deliverables on time and within budget (GMP were applicable)

President of Engineering for Procubed Corporation, an engineering Contractor

Engineering Director for Medovations disposable medical products division

Engineering Group leader at Surgitek’s implantable product department, a division of Bristol Myers Squibb

Project Development Programs with up to 40 direct reports; Planning, schedules, reports, performance tracking, reviews, budgets, customer service and conflict resolution negotiations

Have planned and implemented business startup operations. Setup corporate structure and selected market opportunities. I have led teams that have successfully developed products that are still in production.

WORK HISTORY

Contract Program Management and Engineering services provided Jan 2008 to Dec, 2016

Product design for Baxter Health Care specific to infusion pumps Jan 2016 to Dec 2016

Test Method Validation and Remediation for Baxter Healthcare Apr 2014 to Dec. 2015

Worked with Management and department team to define and create test equipment and processes to repair the device history files for the Elastomeric division. I was responsible for defining necessary test equipment, then to design and build the test equipment. In addition, we developed the protocols to complete testing and documentation for device history file.

Other departments within Baxter Healthcare recognized and utilized my Engineering abilities. Using computer simulation, I resolved the cause of an infusion-pump product hold. Designed and built life cycle test equipment for Baxter’s Home Choice Dialysis equipment.

Program management under NDA for Eaton Corp and numerous GMP and Automation and Design projects Oct 2013 - Mar 2014

Program Management with design & regulatory responsibility University of WI Team project (5D Wheelchair searchable) Mar – Sept 2013

Completed Merz Injectable V&V and vendor resolutions including mold flow concerns (Phillips) (Bi-monthly Design Reviews with findings and resolutions, managed results/DHF.) Jan - Feb 2013

Hakky Medical implant program management (included design, prototype and test) Sept. - Dec. 2012

Program Management and design feasibility for automated production of mission critical thermocouples for the Boeing Dream Liner’s engines. Jan - Aug 2012

Wheelchair project team organization in conjunction with UW System Oct 2011- Dec 2011

Project management and process development for Creation Tech. Jan – Oct 2011

Designed and built automated process equipment Yaskawa International. Utilized PLC controllers and Cognex vision systems. (Utilized Ladder-Logic and Structured Text to control PLCs) April – Dec 2010

Managed project development teams, included product design and process tooling for Intermatic, Watlow and S2S Global Medical Jan 2008 – April 2010

Baxter GIS - Senior Principal Mechanical Engineer 2001 to 2008

(Note: Started as a contractor, hired due to demonstrated results managing a product resolution team.)

Resolved corrective actions for a range of infusion pumps. This included issues for the hardware, disposables, and software interface.

Contract services to Baxter GIS division - 2001 to 2003; Wrote test protocols to identify infusion pump performance enhancements, managed lab staff, analyzed data, wrote reports, and designed process and product revisions. This assignment included process equipment and product design revisions. Multiple regressions were the key to understanding how to improve the product.

Procubed LLC – Principal 2001 to 2015

Engineering contracting, design and build equipment for industry; Cycle test fixtures, structural design, production and QC hardware, automated equipment, product development, project management.

Led prototype development teams, provided design consultation, improved product designs, Developed protocols and documentation, Submitted 510-K applications and Performed Validations. Specific projects included:

Vista Dental, Racine, WI - 1999 to 2001, Contract Engineering Manager; Contract work for Baxter/Clintec; Procubed - Patent development of high efficiency transmission.

Sabratek Chicago, IL - Design Engineer 1994 to 1999

Disposable set redesign, 2 patents issued, now owned by Baxter.

Assisted various types of companies in design and development of consumer and medical goods. Use of strong problem solving skill to improve design of Infusion Pump technology. Designed hardware for Chicago based start-up, prototypes operated as defined.

Reworked a medical infusion pump and the disposable, sterile sets. Also included process and quality hardware design, construction and validation.

Medovations Milwaukee, WI – Product Development Manager 1991 to 1994

Developed surgical products for OEM customers. Introduced three new Medovations products. Re-engineered most of Medovations product line with emphasis on product quality and GMP methods. Was the contact person for an FDA audit and resolved form 483 issues. Validated package sterility and integrity of complete product line. Submitted four 510-k applications to the FDA.

Surgitek / Bristol Myers Squibb Racine, WI 1982 to 1991

R&D Manager 1987 to 1991

Managed engineers and technicians while maintaining some primary project responsibility for Implantable and indwelling urological products.

Senior Project Engineer 1985 to 1987

Responsible for product development with teams made up from various departments. We introduced new Indwelling and Implantable Urology products. Improved production efficiency, product durability, and GMP compliance.

Project Engineer 1983 to 1985

Responsible for Indwelling Urology product development. Product introduction included design, validation, process development, tooling and documentation. Completed 6 product introductions.

Research and Development Technician 1982 to 1983

Performed material tests, invented processes and tooling, established the bill of material, router and inspection procedures.

EDUCATION

Argosy University

August 2013 - Masters of Business Administration (MBA)

University of Wisconsin

December 1983 - Bachelor of Science Mechanical Engineering (BSME)

Training and seminars:

Quality GMP ISO-9000 Clean room procedures Sterilization Packaging Statistics & Six Sigma

AutoCAD SolidWorks Surgery Machine Tools Plastic Processing Welding Joining

PROFESSIONAL ACHIEVEMENTS

Five patents for products in the fields of Mobility Aids, Urology and GI. Other patents issued for consumer products. Produced clinical GI product in conjunction with University Hospital Chicago, IL. Performed Artificial Bladder animal trials at the Mayo clinic Rochester, MN. Designed and developed Thoracic, Urological, GI and LIS products. Three more patents pending for infusion pumps and disposables. Developed a patent pending manual wheelchair in conjunction with the University of Wisconsin System. Resolved an infusion pump issue in a novel way, Baxter has a patent pending for the design.

REFERENCES AVAILABLE UPON REQUEST



Contact this candidate