David W. Cowan

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

Pennsburg, PA 18073

Mobil: 215-***-****

E-mail: ac6hdc@r.postjobfree.com

To whom it may concern:

Please note my phone does not work inside the building I am located in. Please leave a Voice Mail and I will return your call.

Please think outside the box when reviewing my resume. I have a great deal of knowledge and experiences which can be transported to any job function. I have an electrical engineering background, but also enjoy working with my hands, cars, woodworking, home improvements, etc.

As I moved through my career, I have taken many turns and learned along the way. I transitioned from engineering testing to engineering design to engineering management to program management(project management) to manufacturing to process improvement to quality assurance (ISO, FDA). While in my Operations roles, I have applied all of this knowledge to help improve the companies I have worked for. I know I can use my knowledge and people skills and enhance any company or function I am involved with. I have held many positions, but job titles are not important to me. What I enjoy is solving issues and helping the team improve and enhance the company. I have and can be a resource and mentor to other team members. I have worked my way up, so I understand the different viewpoints of many workers. I am an excellent listener. I have worked with several startup companies, have worn many "hats" and understand and can perform many different jobs. I have been instrumental in making change to an organization, but with "buy in" so the change is driven from below with guidance.

In closing, please look at my knowledge and experiences, not job titles, and determine if, as I feel, I can be a benefit to your company. I feel any job I have applied to, the company and I will benefit and it is a good match for both. I look forward to a call from you.

SUMMARY OF QUALIFICATIONS:

Experience successfully managing a variety of engineering, quality and manufacturing operations. Thorough knowledge of engineering, quality, regulatory, cGMP, manufacturing processes, marketing functions and customer requirements. Excellent leadership skills with the ability to assemble, train and motivate highly effective work teams. An accomplished problem solver and decision maker with a record of achieving substantial improvements.

HIGHLIGHTS:

Electrical Engineering designer: designed complex custom devices. Over 27 years managing engineering design.

Quality: obtained ISO certification of over 45 companies. In the Quality field for 18 years. Wrote and obtained clearance from the FDA of three 510k’s. Obtained CE certification for three Medical device companies. Implemented FDA current Good Manufacturing Practices (cGMP) at five different medical device companies.

Process improvement: Cell manufacturing, value stream mapping, Kiazen, non-added value, lean manufacturing.

Automation: Defined and managed the installation of robotic welders, stockroom stocking system and conveyor systems.

Manufacturing: Setup/improved and managed several manufacturing facilities

Inventory and supply chain: reduced inventory by over 200%. Supply chain management for reduced lead time and cost.

MRP/ERP Software: implement systems at three different locations

Profit / Loss: managed P/L of three different companies

Project Management: managed multi projects, maintaining schedule, cost, and delivery to the Customer. 27 years of project management. Managed the installation of equipment at the Customer site, overseeing and scheduling of sub-contractors.

Construction: Electrical work per NEC, plumbing and carpentry knowledge and experience

Software: proficient with Microsoft Word, Excel, Power Point, Visio, Project

PROFESSIONAL HISTORY:

ACERO Precision (West Chester, PA, USA) Nov 2017 – Present

Quality Assurance Manager

Acero is a machine shop of complex medical parts for the orthopedic industries. They also fabricate parts for the test equipment market.

I completed an entire rewrite of the obsolete, disjointed quality system to a new system to meet ISO 9001:2015 and 13485:2016 requirements. Worked with the process owners to get buy in and develop flow chart formatted new procedures for the required processes. Trained all employees, approximately 100 employees (mainly direct) on the new Quality System and requirements. This was completed in six months. Re-enforced FDA current Good Manufacturing Practices (cGMP)

CUSTOM ULTRASONICS, INC (Ivyland, PA, USA) Apr 2016 – Sep 2017

Vice President of Operations

Manufacturing operation for automatic endoscope cleaning equipment. Responsible for all manufacturing operations including production, inventory management, purchasing, information systems, shipping, receiving, storeroom, repair and safety and environmental.

Responsible for all aspects of engineering design, research and development, quality assurance and product and system compliance to FDA and international standards.

•Setup Production scheduling and cell manufacturing to maximize throughput

•Setup Engineering project reporting and good engineering design practices

•Started outsourcing some sub-assemblies to increase throughput

•Implemented FDA current Good Manufacturing Practices (cGMP)

CURVEBEAM, LLC (Warrington, PA, USA) Jan 2009 – Oct 2015

Vice President of Operations, Quality Assurance and Regulatory Affairs (also Partner)

Manufacturing operation for 3D medical X-ray equipment. Responsible for all manufacturing operations including production, inventory management, purchasing, information systems, shipping, receiving, storeroom, repair and safety and environmental.

Responsible for all aspects of engineering design, research and development, quality assurance and product and system compliance to FDA and international standards.

•Obtained ISO certification to ISO 13485 and ISO 9001 within a 6 month timeframe

•Implemented FDA current Good Manufacturing Practices (cGMP)

•Working with Mechanical, Electrical and Software Engineering, developed the Design History File (DHF) for the PedCat, CBCT scanner, manufactured by CurveBeam.

•Wrote and obtained FDA 510k approval for the PedCat, within 8 months of releasing the product from design engineering.

•Wrote and obtained CE certification for the PedCat device

•Setup engineering and business processes compliant to FDA and international requirements.

•Implemented lean flow manufacturing which increased production throughput by 80%

COWAN CONSULTING (Pennsburg, PA, USA) Jan 2009 – Sep 2016

Consulting Manager

Working with several clients, implemented systems, documentation and databases across all areas of a company to obtain certification to ISO 9000 or ISO 13485 or other standards. Assisted companies in implementing process improvements.

Key Clients:

Lone Oak Medical Technologies (Doylestown, PA, USA) Aug 2009 – Sep 2016

QA Manager

Lone Oak repairs the accudxa and manufacturers the accudxa2, Bone Mineral Density (BMD) products

•Created the DHF for the accudxa2, new BMD product.

•Wrote and obtained FDA 510k approval for the accudxa2 device

•Wrote and obtained CE certification for the accudxa2 device

•Obtained ISO certification to ISO 13485 and ISO 9001

•Implemented FDA current Good Manufacturing Practices (cGMP)

•Acted as Quality Assurance Manager for all Quality related actives

Mirrored Motion Works (Cary, NC, USA) Jul 2015 – Jan 2016

COO, QA Director

Mirrored Motion Works is a stroke rehab device manufacturer, their device, Bimanual Arm Trainer (BAT). MMW is owned by two doctors, one a PhD and one an MD.

•Supervised Mechanical and Electrical engineering contractors to convert the concept for the BAT into a designed and released product.

•Using FDA 513g submission, obtained a class 1, exempt status for the BAT device

•Developed the DHF for the BAT device

•Setup Vendor relationships to manufacture, test and ship the BAT to the end Customer.

•Implemented FDA current Good Manufacturing Practices (cGMP) at the manufacturing vendor

•Setup an FDA and ISO 13485 compliant Quality Management System for MMW. MMW does not wish to pay for ISO certification at the present time.

•Setup systems and structure for the company

Britech Company (Allentown, PA, USA) Oct 2015 – Aug 2016

QA Manager

Britech is a contract cable, harness and panel manufacturer.

•Obtained ISO certification to ISO 9001 and acted as Quality Assurance Director for all Quality related activities.

IMAGING SCIENCES INTERNATIONAL (Hatfield, PA, USA) Jan 2007 – May 2008

Vice President of Operations (after purchase by Danaher Corp in 2007)

$120M manufacturing operation for 3D dental X-ray equipment. Responsible for all manufacturing operations including production, inventory management, purchasing, manufacturing engineering, information systems, shipping, receiving, storeroom, repair and safety and environmental.

•Implemented throughput improvements to increase production capacity 300% by the use of standard work, lean manufacturing and waste reduction.

•Within one year reduced the cost of the products by 20% by the use of vendor consolidation, combined spend with low cost regions and value engineering projects

IMAGING SCIENCES INTERNATIONAL (Hatfield, PA, USA) Aug 2004 – Jan 2007

Vice President of Engineering, Quality Assurance & Government Compliance

Responsible for all aspects of Operations, engineering design, research and development, quality assurance and product and system compliance to FDA and international standards.

•Obtained ISO certification to ISO 13485 and ISO 9001 within a 5 month timeframe.

•Setup engineering and business processes compliant to FDA and international requirements.

•Working with Mechanical, Electrical and Software Engineering, developed the DHF for the iCat, dential CBCT device

•Wrote and obtained FDA 510k approval for the iCAT, within 10 months of releasing the product from design engineering.

•Implemented lean flow manufacturing which increased production throughput by 600%

•Grew revenue from $20M to $80M in a 3 year period.

•Implemented FDA current Good Manufacturing Practices (cGMP)

PRISM eSOLUTIONS (King of Prussia, PA, USA) Jan 2001 – Aug 2004

Consulting Services Manager

Working with 12 to 15 clients at a time, implemented systems, documentation and databases across all areas of a company to obtain certification to ISO 9000 or ISO 13485 or ISO 14000 or TS16949 or AS9100 or other standards. Assisted companies in implementing process improvements.

•During a 3 year period obtained compliance and certification of 30 different companies to ISO 9000 or ISO 13485 or TS1649 or AS 9100.

•Implement process improvements at several companies including robotics, cellular manufacturing, kanban, lean manufacturing and out sourcing non-core business task.

COOK SPECIALTY CO. (Green Lane, PA, USA) Jan 2000 – Jan 2001

Project Director/QA Manager (One year project)

Responsible for improving, creating and implementing systems and documentation across all departments to obtain QS 9000 and ISO 9001 certification within 8 months. Recommend operational improvements to increase gross margin and grow the business.

ALLEN ORGAN CO (Macungie, PA, USA) Feb 1998 – Jan 2000

Manager of Manufacturing Operations/Plant Manager

Responsible for all manufacturing operations for two major operations under the Allen Organ umbrella. A $25M manufacturing operation for electronic church organs and a $6M manufacturing operation of contract assembly of complete electronic instruments, PC boards and sheet metal. Managed 350 personnel divided into the following major areas; manufacturing, master schedulers, planners, purchasing, manufacturing engineering, information systems, quality assurance, inspection, shipping, receiving, storeroom, environmental and plant maintenance.

•During a 10 month period reduced total inventory from $14M to $10M.

•Project Manager for implementing an ERP system, QAD, MFG/PRO in two phases. Phase one turned on November 1998 which converted the Contract Assembly operation over to the system. Phase two turned on July 1999 for the organ part of the business.

AVO INTERNATIONAL (Valley Forge, PA, USA) Mar 1993 – Feb 1998

Vice President, Manufacturing/Plant Manager

Responsible for all manufacturing operations for approximately 200 different product lines. Managed 100 personnel. Prepared and managed a $4.8M budget. An officer of the corporation, who defined, established and met corporate goals. Responsible for all environmental issues and served as safety director.

AVO INTERNATIONAL (Valley Forge, PA, USA) May 1991 – Mar 1993

Manager of Power Systems Engineering, Program Manager Custom Projects

Responsible for engineering design of all custom and semi-custom projects. Managed engineers, technicians, draftsmen, engineering machine shop, technical writing of manuals and quotations, plus a field service group.

NEW FRONTIER ASSOCIATES, LLC (Pennsburg, PA, USA) May 2008 – Jan 2018

Owner/Partner

Perform all operations of a real estate investment business. Purchase, rehab, lease and resell residential homes in the Bucks and Montgomery County area. Each property was managed as a project with detailed cost of purchase, rehab, carrying and selling. Several properties are presently rented and several were purchased, rehabbed and resold.

EDUCATION:

1978-1985 Villanova University (night school), Villanova, PA, USA

Bachelor of Electrical Engineering

1975-1977 Spring Garden College, Chestnut Hill, PA, USA

Associate of Electrical Electronic Engineering Technology

Contact this candidate