Dr. Carsten Heil
Dipl. Chemiker, Techn. Betriebswirt (EA)
Vice President Study Development & Integration(The company name is only visible to registered members)
- 97204 Höchberg
- Germany
Personal information
- Haves
- Development of Medical Devices (Hard- and Software, class IIa), Validation, Risk Management, Project Management, Regulatory Knowledge, Quality Management Systems ( ISO 9001, ISO 13485, 21CFR 820), 21 CFR part 11, EN 62304, EN 62366, COBIT, ITIL, CMMI, SPICE, SCRUM, GCP, ICH, GMP, GLP, SOX, CDISC, etc.
- Interests
- Experience other cultures, a good book
Professional experience
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Feb 2011
- present
(1 year, 4 months)
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(Only visible for registered members)
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Feb 2011
- present
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Jul 2006
- Feb 2011
(4 years, 8 months)
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Cardinal Health Research Service, http://www.viasyshealthcare.com
Industry: Medical Devices, Medical Devices, Clinical Trials, Compliance, CSV
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Jul 2006
- Feb 2011
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DHC GmbH, http://www.dhc-gmbh.com
Industry:
- Employment status
- Employee
Educational background
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Universität Bonn
Physikalische Chemie, Promotion
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Fachhochschule Köln
Betriebswirtschaft, Techn. Betriebswirt
- Languages
- German, English
About me
Profile:
Results-focused executive leader of a product development team for class IIa medical devices. Responsibility covers the complete software development life cycle including product management, soft- hardware development, verification, validation and release management. Strong project leadership to ensure delivery of projects in time and quality. Budget responsibility for up to 12 Mio EUR. Creative, goal-directed team player with strong managerial, organizational, and problem solving skills. Deep expertise in applying technological solutions to complex business problems and balance regulatory requirements and business opportunities.
Strong background in process design and implementation, including outsourcing processes to India and agile development strategies for medical devices.Education:
Degree in Chemisty, University of Bonn
PhD in Physical Chemistry
Technical Business Economist (EA), UAS Cologne
Today: Managing the technology of the market leader for support of respiratory trials
Heading a group of 5 product managers area of respiratory, ECG and electronic patient reported outcome (questionnaires) and 4 project managers to build workflow driven medical devices to collect data in clinical trials. Responsibility for 22 internal software developers and up to 55 external consultants to build medical devices in Höchberg. Responsibility for 26 internal software testers supported by up to 40 consultants to test these devices at the same site. Reorganize and grow this department to reach a high CMMI level and introduce new technology and tools. Responsibility for a group of 7 developers in Munich to build software components for medical devices.
Consolidated operations of software development teams in Höchberg and Munich, resulting in shorter time to market without compromising on deliverables and product quality. Successfully outsources testing and development to India by building up a dedicated group of 5 developers and 23 testers in India.
Responsible for the delivery of products within budget, schedule, quality and corporate guidelines. Reporting towards the corporate headquarter in US. Providing employee development, coaching, mentoring and team building especially for the mid management level. Quality responsibility as the listed Safety Officer for Medical Devices for the Höchberg site.Search the XING network
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