Engineer Quality Control

ANTON J. STEINER

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

Wharton, N.J. 07885

973-***-**** acf4dm@r.postjobfree.com

ENGINEERING PROFESSIONAL

Highly motivated Engineer who excels in R&D, Pilot Plant and Manufacturing

environments. Extensive experience in product and process development for

Class II and III Medical Devices, including technology transfer (internal &

external) of metals, polymeric implants and disposables. Excellent

leadership and communication skills. Delivers complex projects on schedule

and within established budgetary constraints.

TECHNICAL SKILLS

Six Sigma Black Belt FMEA Robust Process Design MS

Project/Powerpoint

KT Failure Analysis DOE Lean Manufacturing Minitab

PROFESSIONAL EXPERIENCE:

Cordis, a Johnson &Johnson Company, Bridgewater, NJ 1996 - 2000 & 2008

- 2014

Principal Engineer

Key research and development member of New Product Development Teams,

including design feasibility & manufacturability, process development,

characterization, validation thru commercialization.

. Executed process validation of laser cut coronary stents at contract

manufacturer, utilizing a vision inspection system for acquisition of

variable data for characterization & validation.

. Validated AAA Delivery System insert molding process for endovascular

device being launched during 2014 in EU, technology transferred from

China & Ireland to Cordis Mexico facility.

. Working knowledge of coronary stent crimping and loading processes, as

well as endo stent assembly & loading (collet crimping, tapered funnel

crimping, nesting and heat setting).

. Developed injection molding process for insert molded catheter delivery

system, including transfer & process validation executed to aggressive

project plan.

. Managed pilot plant inspection group of 8 associates performing variable

and attribute inspection of coronary and endovascular stents.

. Excellent coaching and mentoring skills to develop young technical

resources.

MTF, Musculoskeletal Transplant Foundation, Edison, NJ 2000 - 2008

Senior Project Engineer

Designed and developed new applications for allograft tissue forms for

specialized orthopaedic and sports medicine procedures.

. Interfaced with development partners on new allograft designs,

planning projects from concept to commercial release, including design

control, validation, surgeon interface, and tissue optimization.

. Developed instrument systems to support surgeons in transplantation of

fresh articular cartilage allografts for large defects and meniscal

allograft transplantation.

. Performed clinical evaluations with surgeon partners, submit IP,

vendor sourcing, scale-up & commercialize.

. Coordinate testing lab performing biomechanical analysis of allograft

& oversee arthroscopy lab.

ANTON J. STEINER Page 2

SNAP-ON TOOLS Medical

Products, Morris Plains, NJ

1993 - 1996

Senior Project Engineer

Designed, developed and manufactured medical and surgical instrumentation

for orthopaedic, spinal and trauma applications.

. Interfaced with customers to provide design solutions for technical

surgical requirements, which included cost estimation and development

budgets.

. Directed the activities of engineering design group of 6 designers and

3 engineers for all instrument projects, including invention

disclosures and patent application.

. Managed the development engineering group through a management

transition and the scale-up of a new manufacturing facility.

STRYKER Corp. Allendale, NJ 1988 - 1993

Project Engineer

Developed manufacturing processes for Class II & III devices in a

fast paced production environment.

. Developed production capability for application of bio-compatible

coatings, cleaning and passivation lines, Ion Implantation on CoCr

implant surfaces.

. Worked within a Cellular Manufacturing team required to perform all

scheduling, costing and capacity the planning for femoral knee product

line.

. Implement process quality control systems using control charting to

measure quality output.

3M Orthopaedic Products (acquired by Kirchner Medical) Fair Lawn, NJ

1984 - 1988

New Product Engineer

Supervised 3engineering professionals to implement new product and

processes, as well as improve existing manufacturing capability.

. Prepared process specifications, production routings and product

inspection procedures for components in-process in a JIT environment.

. Supervised Quality Control Department, including customer complaint

responses during transition from 3M Orthopaedic Products to Kirschner

Medical, including leadership during FDA Facility Audit.

EDUCATION: NEW JERSEY INSTITUTE OF TECHNOLOGY, Newark, NJ

B. S. Mechanical Engineering Technology

NEW JERSEY INSTITUTE OF TECHNOLOGY, Newark, NJ

Certificate in Manufacturing Technology

PATENTS: Universal Modular Reamer System

#5,499,984 Issued 3/96 Allograft Suture

Anchor #6,508,830 Issued 1/03

BTB Assembly with Cancellous Allograft Block #6,730,124

Issued 5/04

BTB Assembly W/ Allograft Block & Assembly

#6,890,354 Issued 5/05

Bone Tendon Bone Assembly Method #7,137,996B2

Issued 11/06

Method of Inserting Improved BTB Assembly

#7,144,425B2 Issued 12/06

Bone Tendon Bone Assembly #7,201,773 B2

Issued 4/07

Allograft Implant Workstation #7,722,608 B2 5/10 &

#7,780,668 B2 8/10

Vertebral Disc Repair #7,879,103

B2 Issued 2/11

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