David Kinsel, Pe work email
- Valid
- Valid
- Valid
David Kinsel, Pe personal email
- Valid
David Kinsel, Pe phone numbers
I'm a highly experienced manager with domain expertise in quality assurance, new product development, and program management with significant subject matter expertise in 21 CFR 820.30 (Design Controls) and Usability Engineering. I earned a Juran Institute Six-Sigma Black Belt and have eleven issued patents. I am a focused professional and dedicated to solving complex problems and implementing processes in regulated industries. I am a registered professional engineer in Ohio.Specialties:Leading diverse teams to accomplish business-critical objectives in quality systems and product engineering. Documentation and optimization of business and manufacturing processes. Solving complex design and process problems.Domain Expertise:* Cross-Functional Team Leadership * Design Quality Assurance * Six Sigma Green Belt & Black Belt * Talent Management * Critical Project Leadership * Regulatory Compliance / Audits * Resource Management * Procedure Development * Training & Education * Manufacturing Operations * Research & Development * Human Factors Engineering * Product Development * Budget Management * Risk Management * Design Controls * Systems Engineering * FDA / ISO Design Compliance * CAPA Implementation * Requirements Management * Due Diligence Assessments * Critical Project Management * Global Product DevelopmentPlease email me at david.kinsel.pe@gmail.com if you'd like to contact me.
-
RetiredN/ASylvania, Oh, Us
-
Director Of Research & DevelopmentTeleflex Sep 2022 - PresentWayne, Pa, UsTeleflex Incorporated acquires Standard Bariatrics to expand the product offering of the Surgical business unit. -
Director - Research & DevelopmentStandard Bariatrics, Inc Jan 2022 - Sep 2022Cincinnati, Ohio, UsLeading 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. -
Senior Manager, Product Development - Design Quality AssuranceTerumo Cardiovascular Systems Dec 2016 - Dec 2021Ann Arbor, Michigan, UsProvided 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. -
Sr. Product Development Manager - Design Controls Subject Matter ExpertTerumo Cardiovascular Systems Jul 2011 - Dec 2021Ann Arbor, Michigan, UsThe 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.
-
Product Development ManagerTerumo Cardiovascular Systems Jan 2008 - Jun 2011Ann Arbor, Michigan, UsLed 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.
-
Project Engineering Team LeaderNewell Brands Nov 2006 - Dec 2007Atlanta, Ga, UsProvided 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. -
Product Engineering ManagerMasco Aug 2000 - Nov 2006UsManaged 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. -
Manager, Product Development, Quality Assurance, Regulatory AffairsBionix Development Corporation Jan 1996 - Aug 2000Responsible 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
-
Senior Project EngineerGelman Sciences (Acquired By Pall Corporation) Oct 1992 - Jan 1996Lead 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
-
Senior Product Design EngineerThe Jobst Institute (Acquired By Bsn Medical) Oct 1987 - Oct 1992Lead 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.
David Kinsel, Pe Skills
David Kinsel, Pe Education Details
-
The University Of ToledoMechanical Engineering -
Wright State UniversityHuman Factors / Usability Engineering
Frequently Asked Questions about David Kinsel, Pe
What company does David Kinsel, Pe work for?
David Kinsel, Pe works for N/a
What is David Kinsel, Pe's role at the current company?
David Kinsel, Pe's current role is Retired.
What is David Kinsel, Pe's email address?
David Kinsel, Pe's email address is da****@****ail.com
What is David Kinsel, Pe's direct phone number?
David Kinsel, Pe's direct phone number is +141988*****
What schools did David Kinsel, Pe attend?
David Kinsel, Pe attended The University Of Toledo, Wright State University.
What skills is David Kinsel, Pe known for?
David Kinsel, Pe has skills like Cross Functional Team Leadership, Design Control, Quality System, Fda, Medical Devices, Iso 13485, Product Development, Capa, Six Sigma, Design Of Experiments, Validation, Quality Assurance.
Who are David Kinsel, Pe's colleagues?
David Kinsel, Pe's colleagues are Katherine Chase, Todd Leidner, Michael Slusser, Nathan Hall, Kevin Harbour, Brian Hawley-Roth, Brenna Rheinhart.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial