David Coulter Ma Pmp Csm Email & Phone Number

United States

United States

Wayne, Pa, Us

— - Global EU MDR Team Leader for Economic Operators— - Driving the development of a state of the art global labeling organization by integration of a PLM , ERP and UDI systems with labeling systems— - Driving UDI and EUDAMED development and global connection systems to meet MDR and global regulatory and commercial requirements for medical device.— - Large team leader of over 70 people from a wide range of background and cultures successfully completely strategic objectives

Humlebæk, Denmark, Dk

◆ Established a international PMO—- Deployed Plainview PPM Pro software for resource management for over 50 projects—- EU MDR Program Leader for technical and DHF remediation—- Lead an international team of new product development project managers —- Project portfolio creating, tracking and value structure —- Led large scale MDR projects to ensure DHFs meet requirements —- Owner of the KPI reporting and tracking structure—- Established project metrics using Agile Scrum—- Worked cross functionally with the European subsidiary

Eden Prairie, Mn, Us

Harland Medical Systems specializes in hydrophilic coatings, machines and applications for medical devices used for heart, vascular, aorta repair and other areas requiring specialized coatings to enable clinical access to critical parts of the anatomy. ♦ Director with P/L responsibilities over three very different business units ♦ Established and set metrics around KPIs♦ Set priorities for new programs in development coming through development into production♦ Implemented Lean training and Kaizans♦ Improved on time delivery by from 25% to over 75% within 6 months.♦ Reduced manufacturing labor cost and increased capacity. ♦ Designed and implements new and volume pricing for customers♦ Lead a team of over 30 people including director level and middle management direct reports

Eden Prairie, Mn, Us

◆Team leader for new product development programs for FDA / PMA Class 3 implantable.--- Obtained FDA advisory committee (panel) success recommendation--- Managed FDA requirements for the PMA--- Collaborated with medical professionals on the design validation & performance of the device.◆ Led quality system improvement projects (post market risk management)--- Brought 15+ procedures in to compliance with ISO 14971-2012--- Remediated 7 products risk management files to align with the relevant standards --- Executed over 90 product/ process technical reviews to update the risk management system. ◆ Performed the full range of program management activities including:--- Collaborated with senior management on program status, objectives and decisions.--- Collaborated to create a PMO structure--- Created program schedules, budgets and tracked expenditure --- Working with outsource vendors to strategically meet project goals.--- Managing communication and decision making on multiple levels throughout the organization.--- Resource planning and gap analysis for projects.--- Executing project and technical reviews--- Providing leadership and direction to personnel from several functional areas--- Led re-branding project including entire breadth of the company (IT, finance, marketing, labeling, regulatory, quality, legal etc.)--- Led teams with HCL Technologies from India

◆Team leader for new product development programs for FDA / PMA Class 3 implantable.--- Obtained FDA advisory committee (panel) success recommendation--- Managed FDA requirements for the PMA--- Collaborated with medical professionals on the design validation & performance of the device.◆ Led quality system improvement projects (post market risk management)--- Brought 15+ procedures in to compliance with ISO 14971-2012--- Remediated 7 products risk management files to align with the relevant standards --- Executed over 90 product/ process technical reviews to update the risk management system. ◆ Performed the full range of program management activities including:--- Collaborated with senior management on program status, objectives and decisions.--- Collaborated to create a PMO structure--- Created program schedules, budgets and tracked expenditure --- Working with outsource vendors to strategically meet project goals.--- Managing communication and decision making on multiple levels throughout the organization.--- Resource planning and gap analysis for projects.--- Executing project and technical reviews--- Providing leadership and direction to personnel from several functional areas--- Led re-branding project including entire breadth of the company (IT, finance, marketing, labeling, regulatory, quality, legal etc.)--- Led teams with HCL Technologies from India

St Paul, Mn, Us

♦ Powered and Air Supplied respiratory product development and commercialization specializing in battery powered respiratory products for the pharmaceutical and industrial markets. ♦ TEAM LEADER for the launch the TR-600 (electro-mechanical product with embedded software) --- Managed design requirement process from customer feedback. --- Managed product design verification testing to align with requirements and features. --- Ensured strategic alignment for projects with senior managers.--- Collaborated with functional leader to continue funding and resourcing of strategic projects. --- Mentored functional leaders in best practices for product development processes to build consistency across projects. --- Set and managed objectives for cross functional team members in line with corporate strategic objectives for entire platforms of projects to ensure goals were obtained with available resources. --- Determine priorities, resource requirements and budgetary needs for the program in collaboration with quality, manufacturing, engineering and other functional areas. --- Successfully managed the scale-up of the final design to manufacturing in collaboration with the manufacturing technology group resulting in a 97% yield.--- Conducted successful stage gate meetings for the design and business care for product in development.

St Paul, Mn, Us

♦ PROGRAM MANAGEMENT for new product development of class II medical device requiring 510K applications, specializing in products to prevent and treat clinical hypothermia during the peri-operative process including temperature monitoring and auscultation.♦ AREAS OF TECHNOLOGY: Electro-mechanical with PCB and embedded software, Auscultation, Aound attenuation, Injection molding, CNC process for production, Nowoven, Spunbond and Melt blown manufacturing process, Sustainability for medical devices, Infection prevention. --- Led multiple product development teams from idea, concept, feasibility, development, scale up to launch for new medical devices to create new revenue streams.--- Gathered and determined customer requirements for new product ideas via focus groups and visits.--- Led design requirement process for converting customer needs into technical metrics.--- Led design requirements and verification process for embedded software.--- Developed design input specifications for new products to meet customer requirements with technical solutions. --- Led projects with hardware, firmware, software and disposables for new revenue streams. --- Led project teams with CAD designers, electrical engineers on PCA design with embedded software, mechanical engineers, prototypers, marketers and others to launch new products. --- Set and managed objectives for direct reports in order to align with corporate strategic objectives--- Managed relationships with OEM project contracts involving other companies' project team members located different European countries to ensure product requirements were met.--- Managed the design transfer to manufacturing to prepare for product launch. --- Integrated multiple timelines, budgets and resources on several projects from conception to launch to create an integrated project plan. --- Managed and developed R&D budget for each project. --- Developed RACI matrices for teams--- Managed the design transfer to manufacturing,

Us

♦ ARIZANT HEALTHCARE Inc was acquired by 3M Infection Prevention Division in October of 2010♦ Class II Medical device (510K) product development specializing in products to prevent and treat clinical hypothermia during the peri-operative process, clinical temperature monitoring blood and intravenous fluid warming and patient cooling. ♦ AREAS OF TECHNOLOGY: Heat transfer, temperature management, intravenous fluid warming, pressure infusion, electro-mechanical with embedded firmware, films, foams, thermal-electrics and injection molding. --- Developed design input specifications for new products to convert customer needs into technical metrics.---Led multiple product development teams of engineers from concept to product launch for new medical devices which were designed for manufacturing and created new revenue streams.--- Prepared and led product development design reviews to meet NPD requirements for FDA. --- Set and managed objectives for direct reports. --- Managed relationships with OEM project contracts involving other companies' project team members located different European countries. --- Managed the design transfer to manufacturing, --- Lead teams with: CAD designers, Electrical engineers on PCA design with embedded software, mechanical engineers, prototypers and many others in the area of product development and people from other functional areas. --- Integrated multiple timelines, budgets and resources on several projects from conception to launch.--- Integrated risk management plans into the product development system and post launch period--- Led FMEA (Hazard analysis) for new products

ACC LTD is one of the several coffee companies owned by Edm. Schluter & Co. of Nyon, Switzerland. The company's main activities are buying green coffee directly from producers, processing for export and selling contracts globally linked to the New York "C" pricing.Title: Managing Director: (Country Representative for Edm. Schluter & Co)• Overall responsibility for management and development of the business in Tanzania. • Exported 70 containers (18 tons each) of green coffee from Tanzania within 12 months.• Managed a credit pre-financing facility from Swiss bankers in green coffee buying operations• Negotiated with Japanese and Germany buyers of green coffee and working out contract details.

Folkestone, Kent, Gb

MAF UK- Europe (now MAF International) is an international non-government organization specializing in offering aviation and logistics services to development and NGO organizations, United Nations, embassies, hospitals and church organizations throughout Africa and developing countries. Title: Logistics Manager• From a one-man office in 1991, I planned for a larger and broader based service which grew into a 14 staff office with five departments which served 200+ organizations• Financial Management of the department• Offering financial services to 200 organizations.• Overseeing international and local procurement. • Representing MAF in the Tanzania Government i.e. Civil Aviation Board, Ministry of Communications, Ministry of Finance, Ministry of Home Affairs, Customs, Port Authorities, and embassies.• Managing of Local and Expatriate staff i.e. Job Descriptions, evaluations, training, delegation of responsibilities.

Leeds, West Yorkshire, Gb

Xiros Plc, as it is know today is a small medical device company with expertise in developing specialty knitted or woven implantable products in the orthopedic market. Responsibilities:• Supervisor for four other staff in very detailed procedures for processing surgical tools & implantables. • Maintained an accurate record of trace-ability using 'lot histories' • Maintained high standards in quality control

Master Of Arts (M.A.), International And Intercultural Communication

Bachelor Of Applied Science (B.A.Sc.), Construction Engineering