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Medical Engineer

Location:
Hyde Park, UT
Salary:
$160000
Posted:
February 06, 2020

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Resume:

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

Hyde Park, Utah *****

Cell: 256-***-****

Email: adbm9q@r.postjobfree.com

PROFESSIONAL SUMMARY

Senior management skills and experience in multi-plant operations, research and development, and business development. Organizational skills, which monitor productivity as well as promote business growth. Strong mentoring skills, which enable open communication and positive growth.

QUALIFICATIONS

25+ years of progressive responsibilities in:

* Vice President of Operations * R&D Engineering management

* Product Management * Project design

* Quality control/government regulations * Funding solicitation

* Proven presentation/communication skills* New product introductions

* Sales and Marketing * Strategic business planning

* Budget management * Business development

HONORS and ACHIEVEMENTS

·Developed a profitable medical instrument business at Structure Medical

·Increasing the output of the Paragon Medicals Smithfield facility 30% in less than 8 months. Assisted in develping a WOFIE (Wholly Owned Foreign Invested Enterprose) in China, and traveled there many times.

·Promoted to Global Business Unit Manager over all ICU Medical facilities including Mexico, USA, and Italy.

·Successfully transferred or completed three product lines: LIM, OMNI Flow,and Butterfly from SLC Hospira to Costa Rica Hospira.

·Successfully coordinated multiple Food and Drug Administration audits.

·Managing Partner of a smaller independent business.

·Managed operations as well as performed marketing and sales that resulted in 100% business growth within one year of acquisition of Medical Techniques.

·Directed new product development and marketing for multiple medical products.

·Acquired multiple governmental approvals; 510Ks, and patents in the medical industry.

·Solicited financial backing such as venture capital, Small Business Administration, and government grants.

·Improved artificial heart by integrating existing technologies into new findings in fluid dynamics.

·Helped design and assisted in surgical implantations of bio-mechanical devices.

·Designed, manufactured, and introduced a new artificial blood pump.

·Researched and developed “Cath-link” for Bard Access Systems.

·Developed, introduced, and patented angioplasty inflation device.

PROFESSIONAL EXPERIENCE

STRUCTURE MEDICAL,

Vice President of Operations January 2017 to October 2019

Combined with sister companies at the end of Q4 and launched Structure Medical in Madison Alabama at the beginning of 2017. Focused on Orthopedic instruments for the corporation and launched many instrument for hip, knee, and spinal replacements. Responsible for all aspects of the business.

FMI HANSA MEDICAL,

Vice President of Operations of 2 facilities, December 2015 to January 2017

Hired to turn business from a dismal 25% on time delivery, and a 30% lose of margin to a 95-100% on time delivery with all customers and the break even at the end or Q3 of 2016. Combined with sister companies at the end of Q4 and launched Structure Medical in Madison Alabama at the beginning of 2017. Focused on Orthopedic instruments for the corporation and launched many instrument for hip, knee, and spinal replacements. Responsible for all aspects of the business.

PARAGON MEDICAL. Smithfield, Utah

Director of Operations for the facility. March 2007 to December 2015

Within 8 months of taking control of the Paragon facility in Smithfield, Utah which uses CNC machines to produce artificial joints, screws, and equipment related to orthopedic spines and sport medicine. Achieved 30% growth to plant production, and at a minimum of 15% growth as it relate to EBITDA (Earnings before interest, taxes, desperation, and amortization) each year after. Continuing to enhance global experience by interacting with major customers within the States, as well as throughout Europe. Presently, assisting cooperate in opening a plant in China. My duties include: Plant operations, facilities, engineering, procurement, customer service, budgeting, R&D, quality, as well as any other cooperate initiatives. Familiar with all aspect or ISO 13485, and wells as FDA requirements. Continues improvement, lean training and knowledge of special process validations have helped to place Paragon Utah as best in operations.

ABBOTT LABORATORIES /HOSPIRA/ICU MEDICAL, Salt Lake City, Utah

Business Unit Manager for Surgicare/Critical Care Product Line 2003 to March 2007

First hired by Abbott Laboratories as a senior validation engineer, responsible for developing a validation strategy and implementation of that program. Responsibilities include the validations of Abbott SLC molded commodities and processes. Validations include writing and implementation of installation qualifications (IQ), operation qualifications (OQ), process qualification (PQ), and process validation (PV), molding experience, design of experiments (DOE), and general engineering tools used in validations.

Recruited to lead the Abbott new leader program, which is a program used to train and help develop key employees for future leadership positions at the Abbott Corporation. Within eleven months of being hired, was promoted to business unit manager responsible for 100 employees including product engineers, process engineers, line techs, operators, facilities, and support teams, which produced products from catheters (TDs, CCOs, etc.), vacuum containers, and drug delivery products. Responsible for the management of large budgets in this division, with high volume production. Duties include all aspects of plant operations i.e.; engineering, R&D, manufacturing, molding, budgeting, human resources, problem solving, sterilization, and final product release. Was given engineering and management responsibilities over all ICU plants worldwide (Mexico, Italy). Knowledgeable in the lean manufacturing, cGMPs and regulatory requirements, and 6-Sigma Green belt certified.

MEDICAL TECHNIQUES INC. North Salt Lake, Utah.

Managing Partner 1996 to 2003

Developed a successful custom packaging company that designed and manufactured surgical packs for physicians and hospitals. Built a thriving business based on quality, competitive pricing, and timely services. Responsibilities encompassed project management, manufacturing, engineering, regulatory affairs, injection molding, and sales and marketing. Wrote protocols and procedures required by the FDA, and successfully completed two FDA audits over six years with no warning letters. Other responsibilities included funding, budgeting, sales, customer service, human resources, sterilization and other business transactions.

SURGICAL TECHNOLOGIES. Salt Lake City, Utah.

Bio-Medical Engineer/Project Manager 1993 to 1996

Project Manager responsible for the product design and launch of a PTCA (Angioplasty) inflation device, and other devices developed by Surgical Technologies. Responsibilities included design, clinical trials, and manufacturing engineering e.g. injection molding, process validation, developing standard operating procedures, creating bill of materials, production scheduling, and labor costing. Experienced in IQA, FQA, and most other regulatory affairs required by a medical manufacturing and supply company. Experience with clean room practices for production, and with sterilization of product.

BARD ACCESS SYSTEMS Salt Lake City, Utah.

Research and Development Engineer 1992-1993

Produced, designed, and tested products for the Cath-Link Project product launch. Developed test protocols related to reliability accelerated age testing and functional experiments for products in the pre-market stage. Demonstrated ingenuity in testing products in vitro as well as in vivo.

THE INSTITUTE FOR BIO-MEDICAL ENGINEERING Salt Lake City, Utah.

Lab Technician followed by Bio-Medical Engineer 1987-1992

Responsibilities included hemo-dynamic flow studies in artificial hearts, catheters, and other fluid filled devices. Experienced in techniques used for flow determination such as Laser Doppler Anemometry, Pulse Doppler, and flow visualization techniques. Experienced with manufacturing computer aided solid works design (cad-cam programs). Assisted and observed in surgeries for implanting artificial hearts, and other bio-medical devices both in human and animal models. Assisted in postmortem examinations, and collaborated with Principle Investigators and physicians involved with artificial blood pumps.

EDUCATION

M.S. Mechanical Engineering, September 1992; University of Utah, Salt Lake City, Utah.

B.S. Mechanical Engineering, March 1990; University of Utah, Salt Lake City, Utah.

PUBLICATIONS

First author and co-author of three manuscripts and five abstracts.

1. Early results from flow measurements in a Utah-100 ventricle. ASME adv Bioengineering 20:477-480, 1991.

2. Working toward metabolic control of artificial hearts by oxygen delivery and utilization monitoring. Inter J Artif Organs 19(9):560, 1990

3. Qualification of intraventricular flow patterns of the human Utah-100 TAH by flow-field visualization. 1992.

ABSTRACTS

1. Continuous physiologic monitoring can indicate the adequacy of cardiac output in the awake, instrumented calf following TAH implantation. Abst AM Soc Artif Intern Organs, 18:12, 1989.

2. Progress made in the third year of development of a totally implantable electrohydraulic total artificial heart. (Abst) Cardiovasc Sci Tech: Basic applied EE, Precised Proc, pp 310-312, 1990.

3. Acute heart failure in a large animal model for cardiac assist device evaluation. Abst Am Soc Artif Inter Organs 19:53, 1990.

4. Small (20 cc) semisoft ventricles for infants. Abst Am Soc Artif Inter Organs 19:2, 1990.

5. Qualifications of intraventricular flow patterns of the human Utah-100 by flow field visualization. Abst In Soc Artif Inter Organs 21:13, 1992.



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