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PETER JOHN MINCIELI

**** ** *** ****** • Pompano Beach, FL 33062 • Phone: 954-***-**** • adwwc1@r.postjobfree.com Medical Device Professional

Increase Profitability / Maximize Shareholder Value / Expand Business Scope National & International Arenas / Strong Technical Orientation QA/Regulatory/Operations executive with 25 + years of successful and progressive experience in manufacturing, new technology and product/process development, all Quality Control and Regulatory Affairs functions and all aspects of Operations, and facilities management. Demonstrated record of developing and implementing new manufacturing processes and facility modifications resulting in multimillion dollar cost savings. Demonstrated record of hands-on success in the startup business arena. Demonstrated record of successful FDA interface. Core Professional Strengths:

Quality assurance and FDA (regulatory) P&L responsibility Change Agent Process improvement

Employee empowerment/team building Business/Technology evaluation Technology integration and maximization New product launch/rollout International product transfer New facility setup

Early Stage Startup Expertise

Professional Experience

C.O.O. – NUTEK Orthopaedics, Inc. 2014 to Present

V.P. Operations - NUTEK Orthopaedics, Inc. 2010 to 2014 Consultant/V.P. Operations – NUTEK Orthopaedics, Inc. 2006 to 2014 Consult with a new Medical Device start-up company to establish it’s working infrastructure. Perform as necessary to get this company’s first sterile product to market within an extremely limited timeline. First sterile product manufactured and placed on sale within seven months of design approval.

• Established company infrastructure to include authoring, writing, training and implementing a complete quality system

• Established a compliant purchasing system.

• As FDA official correspondent, lead the company through its first successful FDA inspection (March 2008).

• Designed packaging for the first sterile devices

• Responsible for filing 510(l) applications with the FDA for newly developed devices Page 2 of 3

PETER JOHN MINCIELI

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Professional Experience

President/Owner – Healthlink Associates, Inc. 2014 to Present Independent Consultant 2005 to ongoing

• Perform as an independent consultant to medical device companies and investors seeking to acquire either technology or complete company structures.

• Review individual pieces of technology developed for use in the medical device field and report on state of readiness and marketing relevance of these devices in preparation for acquisition.

• United States Agent and Official Correspondent for foreign manufacturer of medical devices imported in to the Unites States.

• Regulatory consultant for both Foreign and United States manufacturers of medical devices.

• Filing of various Pre-market approval applications [510(k)] for Clients. Healthlink Associates, Sunrise, Florida 2000 to 2008 President

• Establish a startup Medical Billing and consulting company specializing in collection of outstanding funds billed by medical professionals. Solely responsible for location and marketing of this tight knit group of professionals. Consulted for various medical professionals in practice management procedures. Consulted in the requirements of the new HIPPA Privacy laws regarding patient confidentiality. Investigated PIP cases on behalf of various attorneys on a contract basis. Consulted in the proper use of medical ICD-9 and CPT (diagnosis and procedure) coding to assure proper billing reimbursement. Established successful relationship with the State of Florida Insurance Commission to assure reimbursement of claims filed to insurance companies that have filed bankruptcy. Licensed Independent Adjuster for the State of Florida

Z-KAT, Inc., Miami, Florida 1999 to 2000

Consulting Senior Vice President

Responsible for Design, Fabrication, Company Structure, Fund Raising. Consulted on the design of a Surgical Robot. Specified the fabrication methods and costs associated with the above.

• Wrote and Implemented the Quality System to comply with FDA, GMP and ISO standards.

• Implemented financial controls and assisted in the Seed-Round funding of the company.

• Responsible for all QC activities

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Professional Experience

GENERAL ORTHOPEDICS, INC., Cambridge, Massachusetts 1997 to 1999 Chief Operating Officer (8/98-2/99)

Senior Director of Engineering (2/97-8/98)

Wrote and implemented a quality system

Completed the development of a new intramedullary nailing system Instrumental in selling assets of the company upon closing HOWMEDICA, INC., Rutherford, New Jersey 1981 to 1998 Director - New Technology Development (1/96-2/98)

Assistant Director of New Manufacturing Technology (1/91-1/95) Manager, Special Projects (1/86-1/91)

Senior Manufacturing Engineer (6/82-1/86)

Manufacturing Engineer (5/81 – 6/82)

References available upon request

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