RONALD BURKE

Excelsior, MN *****

952-***-****

abhnm2@r.postjobfree.com

SUMMARY of QUALIFICATIONS

Senior executive with extensive leadership, Operations/Quality and Technology experience. Diverse

background in large corporations, start-up and contract manufacturing companies that produce medical

device, drug and electronic products. Provides vision, strategic planning and implementation, EBITA

improvements, and turnaround/change management. Skills include managing multi-site locations, P&L

responsibility, budgeting/pricing, capital project planning and control, and new product development and

roll-outs. Managed Sales/Marketing, R&D, Engineering, Manufacturing, Quality/Regulatory Affairs,

Clinical, Finance/Accounting and Human resources. Re-engineered a failing company and restored it to

profitability and growth. Comfortable working with all levels, from board members and investors to shop

floor personnel. Tenacious in achieving company goals and profitability. Strong team builder that provides

subordinates with clear direction, tools, training, feedback and mentoring. BS Chemical Engineering, ME

Industrial Engineering, MBA, and Lean Six Sigma Black Belt.

PROFESSIONAL EXPERIENCE

Antares Pharma Inc.

Directory of Quality/Regulatory Affairs/Suppler Management 2012 to Present

Responsible for quality assurance, regulatory affairs and supplier management in a company that

produces injection molded self-injection systems used with parental pharmaceutical products. Fluent in

ISO 13485, 21CFR 820, 210 and 211 regulations.

• Responsible for oversight of agency and notified body inspections and audits, and a Quality

Management System.

• Provides leadership and tactical guidance for QA functions, including Design Controls, Testing and

Inspections, Document Control, Complaint Handling, Auditing, Sterility Assurance, Production and

Process Controls, Supply Chain and Distribution QA, and Supplier Quality Assurance.

Disc Dynamics Inc.

Vice President and Chief Operating Officer 2002 to 2011

Responsible for a Class III medical device start-up that produced a polymer implant, plastic disposables

and electro-mechanical deliver systems for human spine disc repair. Responsibilities included

Manufacturing, Accounting/Finance, R&D, Quality/Regulatory Affairs, Clinical Affairs and Human

Resources. A key team member in raising $65 million in capital funding.

• Managed regulatory and preclinical development projects resulting in a FDA sanctioned U.S.

feasibility study.

• Successfully took the company from a laboratory scale operation to a full-scale validated aseptic

manufacturing facility which received ISO 13485 certification.

• Worked closely with company’s medical advisory board and customers (surgeons) to develop an

electro-mechanical injection system and surgical instruments used to deliver implants through a

minimally invasive approach.

• Managed the company’s intellectual property portfolio program resulting in 22 issued patents and

42 pending applications.

Company closed due to continued FDA changes in requirements for a US pivotal study.

Memry Corporation 2000 to 2002

Vice President and General Manager

Re-engineered a $75 million contract manufacturer with three plants (Bethel, Connecticut and Menlo

Park, California) and over 300 people. Major customers were Medtronic and Boston Scientific.

The products were semi-finished materials, formed products and value-added sub-assemblies

composed of Nitinol (nickel/titanium). The products are used in orthodontics, interventional cardiology,

neurology, vascular surgery, guide-wires, endo-surgery, laparoscopy and orthopedics. Reported to the

CEO.

• Increased sales by 20% while taking the company from the brink of bankruptcy to profitability.

• Implemented a Finite Capacity Scheduling / MRP system used to improve efficiencies in

the manufacturing process for 350 SKU’s. Also used for product costing and pricing models.

• Reduced scrap by $3 million in 8 months using Lean Six-Sigma Methodologies.

• Doubled manufacturing output while reducing delivery time from 16 to 3 weeks.

• Improved yields for the company’s major product lines from under 75% to 98%.

Tyco Electronics 1998 to 2000

General Manager

Led the operations of a $150 million Tyco company that manufactures and assembles injection/insert

molded products for the electronics, telecommunications, aerospace and automotive industries.

• Increased sales volume by 15% while reducing headcount 20%.

• Improved on-time delivery from 85% to over 98%, while reducing inventory by over 75%.

• Relocated a company division, hired and trained all new personnel, and set a shipment record.

• Implemented a Finite Capacity Scheduling / MRP system, used to provide time standards,

product tracing and optimal manufacturing schedules.

Position eliminated when the company was consolidated within Tyco.

Manufacturing Consultant 1996 to 1998

Led the change management effort to optimize manufacturing processes, plant layouts and logistic

operations. Improved laminate yields from 50% to over 98% using lean six sigma methods.

Primary customer was WL Gore-Filters Division which manufacturers Gore-Tex filter materials for

medical device, high purity water and microelectronic clean-room applications.

Johnson & Johnson / Therakos 1992 to 1996

Director of Operations

Directed manufacturing of a $200 million company that produced a Class III combination product

(medical device and drug) used to treat Cutaneous T-cell Lymphoma.

Position eliminated when all manufacturing operations were successfully outsourced.

Amp Inc. 1980 to 1992

Director of Process Engineering

Directed the Corporate Process Engineering group responsible for troubleshooting injection molding

and electroplating processes in a multi-billion dollar electrical connector company.

EDUCATION

Pennsylvania State University

Masters of Management in Business Administration

Masters of Engineering in Industrial Engineering

State University of New York at Buffalo

Bachelor of Science in Chemical Engineering

Northwestern University Kellogg School of Management

Johnson & Johnson Executive Management Program

Air Academy Associates - Lean Six Sigma Black Belt

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