Creekview provides expert consulting services to medical device clients. Primary areas of focus include:• Product development: R&D, product design, process development, QMS activities, validation, product/performance evaluation, and program/project management.• Business development: market opportunity, strategic planning, product plan and organizational evaluation.• Problem solving: root cause analysis, corrective action plan development and solution implementation relating to issues with development programs, process development and validation, manufacturing yields and customer complaints.

Managed all aspects of the Molding Operations Engineering and Quality Assurance Departments. This includes customer relations, validation plan development and implementation, inspection (incoming, in-process…), DFM, quality system, automation and general support to the Operations Team. • Within my first year at Dynamic Group, we achieved a historical high in New Income.• Directly provided value-add to Customers in the areas of Design for Manufacturability (DFM), Design for Process Validation (DFPV) and root cause analysis of quality issues of their components/designs.• Identified opportunities to “standardize” metrology with key Customers. This had an immediate impact on reducing Customer complaints, returns and impact on respective production scheduling and throughput.• Continuous evaluation and update of Quality System to ensure compliance per ISO-13485 as well as Customer specific requirements. This includes activities surrounding all audits and potential corrective actions.• Reduced scrap from 40% to less than 4%, while staying within the confines of an existing validated process, for a high revenue product line.

Managed all aspects of the Plymouth Design Center’s Engineering Department including P&L, design engineering, project management, customer relationships and transfer to manufacturing.• Represented Sparton with potential and existing customers by supporting sales, generating development proposals and contract negotiations.• Closed out the backlog of projects that were behind schedule by implementing new Product Development process resulting in the transfer of four projects to manufacturing (not including separate PCBA projects).• Updated areas of QMS, per ISO-13485, to better serve the Design Centers current scope of Customers.

Developed and implemented strategic plan for the Company’s entrance into the medical device and healthcare markets. This resulted in a plan that combined “short term” component contract manufacturing with “long term” co-development/license opportunities. • Leadership role in recruitment of new board members and $22.5 million Series B financing.• Identified market opportunity and worked with operations to develop implantable MRI compatible material. This resulted in co-development agreement with a leading CRM Company.

General Manager of Maple Grove, MN facility, head of disposable device product development and operations.• Responsible for all acquisition, licensing and strategic partnership activities including relationship management• Responsible for identifying new clinical and product opportunities including management of Physician sponsored research. Resulted in market launch of Company’s first Interventional Cardiology products and sponsored research agreement and joint post market clinical study with leading CRT Company.• Co-developed strategy and co-wrote FDA regulatory submission to broaden indications beyond cardiology. This allowed first human use in pulmonology, peripheral vascular and interventional neuro-radiology.• Chartered and lead advanced concepts team made up of members from disposable device, software and capital systems to foster cross departmental evaluation of new clinical, product and technology opportunities. • Prepared facility, hosted and successfully passed ISO, FDA and GMP audits.

Responsible for strategic and operational management of all Company activities.

• Developed strategic plans and initiated product development programs for SCIMED’s/Boston Scientific’s entrance into the following markets: Carotid Stent, Endoluminal Stent-Graft, Cardiovascular and Peripheral Vascular Metallic Stents, Hydrophilic Guidewires and Peripheral Small Vessel Balloon Catheters.• Developed Company's plastic coated hydrophilic guide wire technology platform and brought to market the Controlwire, SCIMED's first guide wire and first PTA product.• Lead team that designed and built XTRA silicon coating facility and equipment used to coat all balloon catheter products.