David Kinsel, Pe Email & Phone Number

Sylvania, Oh, Us

Wayne, Pa, Us

Teleflex Incorporated acquires Standard Bariatrics to expand the product offering of the Surgical business unit.

Cincinnati, Ohio, Us

Leading a team of talented design engineers supporting a family of transformational devices to enable significantly improved outcomes in bariatric surgery. Adding value through project management and technical contributions for new product development, product improvements, and sustaining engineering.See the Titan SGS(R) being used in procedure comparison videos on the company's website! The link below shows how clearly superior this device is for helping the bariatric surgeon safely and effectively achieve optimal clinical outcomes. The other link below is to FDA guidelines include labeling recommendations that cover the risks specifically associated with the crossing of staple lines. The Titan SGS 23 cm continuous staple line enables surgeons to plan and place staples in one firing, minimizing variations often associated with the current use of multiple overlapping short-cartridge staple firings.The Titan SGS linear cutter is the only device specifically intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation.

Ann Arbor, Michigan, Us

Provided focus and oversight to quality system elements spanning requirements development and administration using INCOSE establihed best practices supporting new product development projects and legacy product life-cycle management. Leading a small core team of professionals and dotted line reports from product platform project teams we bracketed the new product development process by ensuring rich requirements were established and traceable from user needs to the results of design validation and risk management activities. In this role, I also fostered a total quality mindset within the organization by providing formal training and mentoring of less senior engineers in the application of a user-centered design process within the Terumo design control process.

Ann Arbor, Michigan, Us

The leader of the Design Controls element of a task force responsible for the review and optimization of the site quality management system. Activities performed following 8D CAPA process including gap analysis, containment, root cause determination, and corrective actions and verification of effectiveness. My team of 16 and I created and revised processes as needed to establish design controls and related procedures to ensure regulatory compliance as well as the efficiency of execution. At various stages, we developed and provided training to the users and stakeholders. As the subject matter expert, I was very engaged consulting on the application of the design control processes and procedures with product development project teams and for product design changes at the site and representing these processes to investigators and auditors during the quality system certification process and other periodic inspections.

Ann Arbor, Michigan, Us

Led a team of fifteen engineers and coop students to work with cross-functional contributors from Marketing, Regulatory Affairs, Quality Assurance, Operations and Supply Chain Management, and component suppliers to deliver world-class medical devices to aid the cardiac surgeon.* Data-driven problem solving employing six sigma techniques and design of experiments* CAPA implementation* Departmental and project budgetary accountability* Coordinated associate observations of CABG and valve replacement procedures with cardiothoracic surgeons at the University of Michigan for the purpose of user environment familiarization and surgical team task analysis.

Atlanta, Ga, Us

Provided new product development process expertise and program management for multiple cross-functional teams. Concurrently implemented an enterprise project management system and trained three direct reports and over thirty additional users on its use. Applied Six-Sigma continuous improvement principles to analyze issues to improve product quality.

Us

Managed eleven direct reports supporting new product development and product improvements. Worked with marketing, operations, quality, and engineering to define and document an efficient product development process. Using this process the company was able to dramatically expand its product line and improved product introduction effectiveness. After obtaining the Juran Institute Six Sigma black belt I applied these tools and techniques to develop and optimize production processes at satellite component manufacturing plants and advised other six-sigma teams on their projects. These projects were targeted at improving yields and efficiencies in raw material processing, machining. and finishing.

Responsible for translating physician ideas into marketable Class I and Class II medical devices. Created and implemented a quality management system compliant with 21 CFR Part 820. Management representative to FDA. Experience preparing 510(k) submissions. Awarded several patents. Hired, trained and mentored a cadre of young engineers to expand capabilities and capacity for supporting the needs of the business. Information on Bionix products can be found at http://www.bionixmed.com/MED_Pages/MedProductDirectory.html

Lead engineer and program manager on multiple projects developing OEM and proprietary single-use medical device sub-assemblies for fortune 100 medical device companies. Supported ISO quality system certification with objective evidence with design history files for the Micro I.V. development effort that I managed. Supervised other engineers on product/process development projects. Selected to participate in a "Dream Team" to identify and collaborate with clinical thought leaders to develop innovative new applications for the use of company microporous membrane technology for new markets. Awarded utility patents for in-line dental water filtration as a result of this effort. Micro I.V. information can be found at http://www.pall.com/main/oem-materials-and-devices/product.page?id=4339

Lead engineer developing electro-mechanical medical devices incorporating pneumatics and embedded software controls for the prophylaxis and treatment of vascular disease. Facilitated supplier quality and design transfer following cGMP.

Bachelors, Mechanical Engineering

Graduate Level Study, Human Factors / Usability Engineering