SUMMARY
25 years of career success and management experience in all aspects of Product-/ System Development, Engineering and Software Development in highly regulated environments (IVD e.g. bloodscreening, Molecular Diagnostics, Medical Devices).
Served in several management positions @ Roche and Siemens in Germany and California (6 years total in two US delegations), self-employed since 2/2012
Excellent verbal and written communication & presentation skills applied with senior management, international development teams, regulatory agencies and customers.
Management experience directing the activities of R&D teams, international/ interdisciplinary teams, and salaried employees.
TRACK RECORD
Independent Diagnostics Professional; www.your-ideas.net since 2/2012
Based in California; Bay Area, Germany; Munich South
Serving clients since 2/2012 in US and EMEA (office based in California and Bavaria) e.g. major global IVD companies, Swiss instrumentation provider, consulting-/ tool-/ and training providers and various molecular diagnostics start-up companies with:
Interdisciplinary Product-Development/ System Engineering
• Requirements Engineering
• Product Risk Management
• Configuration Management
• Verification & Validation
• Project Management
• Documentation Management
Process Development, Training and Implementation
Design Control (21 CFR Part 820, ISO13485) with the processes above
Management Consulting
Complex decision processes, automation, product design, technology assessment, intellectual property, organization
Siemens Healthcare DiagnosticsE rlangen, Germany
• Director Business Development 8/2011 – 1/2012
Reported to the Siemens Healthcare CTO.
Defined strategy, content and process for the intellectual property improvement initiative in the healthcare sector.
Siemens Healthcare Diagnostics DX Molecular Business Unit
Berkeley, California USA
• Director Engineering (Delegation) 2/2008 – 7/2011
Initiated restructuring of engineering R&D resources for 100 M$ business unit, as result gained engineering budget reduction by 50% and speed-up of molecular product development schedule by 30%.
Acted in system development program management role for the business unit’s product portfolio, supporting all molecular diagnostics programs & platforms (6 direct reports).
Established state of the art system development processes for requirements engineering, risk management and configuration management.
Developed and introduced a molecular automation platform strategy for the nucleic acid preparation/ molecular IVD product portfolio utilizing 3rd party components.
Executed technology assessments of external IVD instrumentation platforms.
Siemens Healthcare Business Development
Erlangen, Germany
• Director Molecular Medicine: 6/2006 – 1/2008
Responsible for the feasibility phase of the Quicklab System (instrument, software, CMOS chip, cartridge, reagents).
Provided disease oriented workflows utilizing imaging diagnostics, IVD and drugs.
Provided product- and project scenarios for molecular diagnostics future platforms.
Roche Molecular Diagnostics
Penzberg, Germany
Manager Systems Development: 7/2002 - 6/2006
Responsible for design control (e.g. requirements management, risk management
process, system & assays validation planning) for multiple platforms (Bloodscreening s401: HBV, HIV, HCV, COBAS CAP TaqMan, Light Cycler) in an international interdisciplinary team environment (multiple US sites, Germany, Switzerland).
Directed system integration team of masters: Molecular Biology, Informatics, and Electrical Engineering (4 direct reports).
Roche Molecular Systems, Inc.
Pleasanton, California USA
• Manager Regulatory Affairs (Delegation) 2000 – 2002
Managed the provision of all instrumentation/ software submissions (PMA’s, 510k’s ) for the Roche PCR products (also bloodscreening) in contact with FDA’s CDRH/ CBER.
Harmonized risk analysis processes between Roche in...
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