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FRANK GREGORY, JR.

**** ******* ****

Racine, Wisconsin 53402

262-***-****

acxjhx@r.postjobfree.com

BACKGROUND SUMMARY

Sr. Product Development Engineer with over twenty years of progressive project accomplishment in the design, development, manufacture, and testing of medical devices. Proven abilities to create innovative product solutions and lead a cross-functional project team from product concept to launch. Skilled in Microsoft Project, Outlook, Word, Excel, PowerPoint, AutoCAD, Failure Mode Effects Analysis (FMEA), CAPA evaluations, Design Controls, technical writing, product test methods and test instrumentation, preparation, execution, and data analysis for Design Verification and Validation protocols.

PRODUCT DEVELOPMENT

• Patent #4,913,683 Infusion Stent System for non-invasive delivery of contrast media into the upper urinary tract.

• Patent #4,932,938 Urethral Indwelling Catheter with Incontinence Control for restoration of voiding control to retentive or incontinent male patients.

• Patent #5,571,014 Dental Non-reusable Torque Limiting Wrench – miniature plastic and stainless steel instrument for installing dental implants.

• Patent #6,187,017 Retrieval Basket Surgical Device for dilating the ureter and capturing calculi.

• Patent #7,101,379 Retrieval Basket for a Surgical Device and System and Method for Manufacturing Same – universal application a traumatic nitinol shape memory basket and variable flex sheath for removal of calculi and foreign bodies from the kidney, ureter, or bladder.

• Completed four (4) new product development projects in first seven months with Surgitek.

• Completed eight (8) new product development projects in first twelve months with Mox-Med\ Moxness.

• Completed six (6) product development projects in twelve months with ACMI Circon.

• Developed intravenous needle-less check valve set which significantly reduced infection transmission risks to healthcare providers.

• Won first place in Circon division wide Surgical Irrigation System design contest.

MANUFACTURING

Developed and implemented new thermoplastic and silicone molding, extrusion, forming, and machining methods for indwelling and disposable medical devices. Part development for Injection molding. Drafted and implemented manufacturing, quality control and quality assurance procedures. Developed fabrication and assembly processes for stainless steel and metal alloy orthopedic surgical instruments and medical devices. Surgical products lean manufacturing team leader. Implemented process improvements via cellular manufacturing.

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FRANK GREGORY, JR.

PROFESSIONAL EXPERIENCE

National Alliance on Mental Illness, Racine County, Case Manager of 20 adults, 6/12 to 1/16

linking the disabled with community services, housing, education, and employment.

ADECCO, at SC Johnson & son, Inc. Racine, WI, Contract Engineer 4/10 to 10/11

Performed prototype testing for globally sourced electrical devices. Set up and troubleshot a three dimensional prototype printer for the rapid prototype center.

MOLDED RUBBER & PLASTIC Corp., Butler, WI, Application Engineer 2/07 to 1/09

Developed processes and tooling for silicone over molding of orthopedic and laparoscopic instruments. Assisted with ISO 13485 Documentation. Equipment specification and procurement. Trained in Lean manufacturing techniques.

AEROTEK/ FIRSTECH/ ADECCO, Contract Engineer 4/03 to 1/07

Assignments: Baxter Healthcare, GE Medical Systems, SC Johnson & Son

Prototyped and developed verification tests for peritoneal dialysis irrigation devices.

Developed governmental regulatory Essential Requirements Checklists and labeling for cardiology and clinical monitoring supplies and accessories. Coordinated cost reduction projects for Computerized Tomography scanner components. Conceived and prototyped new products for the Delivery Systems Technology Platform group. Test data analysis.

ACMI CIRCON, Racine, WI, Project Engineer 8/96 to 6/02

Developed detailed specifications, project timelines, prototypes, and manufacturing processes for surgical irrigation devices. Drafted and maintained invention and design records (DHF), and manufacturing and inspection procedures. Prepared and executed Design Verification and Validation, and process validations. Conducted design control reviews, CAPAs, and risk management FMEAs. Developed an antimicrobial hydrophilic coated ureteral stent. User Acceptance testing and 3rd party vendor coordinator. Supervised technician, design, and prototype shop staff. Conducted IP reviews and competitive product assessments.

MOX-MED\ MOXNESS, Portage\ Racine, WI, Sr. Project Engineer 3/95 to 8/96

Designed and developed manufacturing processes for cataract surgery and IV irrigation disposables, nutrition tube assemblies, self-sealing valves, and custom silicone medical devices. International accounts primary contact. Supervised Engineering staff.

CIRCON SURGITEK, Racine, WI, Sr. Project Engineer 1/94 to 3/95

Cross-functional project team leader for new product development of disposable surgical irrigation and infusion devices. Drafted and conducted test protocols for validating manufacturing processes.

SNAP-ON Medical Products Division, Kenosha, WI, Sr. Project Engineer 6/92 to 1/94

Designed stainless steel orthopedic surgical instrumentation and miniature plastic assemblies. Conceived first Nitinol tube flex shaft orthopedic drill reamer.

Approved product pricing, production floor routings, and bill of materials. Assisted in ISO 9001 certification through development of standard engineering procedures and product development documentation. Supervised design staff.

SURGITEK\ ZIMMER, Bristol-Myers, Racine\ Warsaw, IN, Product Engineer 6/84 to 1/92

Developed thermoplastic, silicone, and stainless steel medical device assemblies for urology. Designed and validated tooling, fixtures, and new manufacturing processes for molding, extrusion, machining, assembly, and testing of medical devices.

Developed instruments for first cementless Titanium Hip Implant System.

EDUCATION

M.S., Management courses completed, Cardinal Stritch College, Milwaukee, WI

B.S., Mechanical Engineering, University of Wisconsin-Parkside, Kenosha, WI

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