Frankfurt Rhine-Main Metropolitan Area
Pharmaceutical professional with over several years of experience in Medical Devices development and Validation Management. Certification management Safety certification
Project Manager - • Requirements engineering • Development of consumable accessories for medical devices • Planning of hardware and software projects, budgets, internal and external resources Procurement of technical equipment and engineering services • Development and design of electronic components for medical devices (for compounding machines in the pharmacy environment) • EMC planning and testing of medical devices and laboratory equipment • UL and CE certification for IEC 60601-1 and EN61010 (medical electrical devices) • Project management registration and usability in the FDA 510k exempt procedure • Preparation of international production documents for OEM manufacturing Hardware and consumables • Training of international employees to produce medical devices by OEM manufacturers. • Lead trainer for international FSE training • Global support of internal and external customers • Presentation on international trade shows
Project Manager Electronics - Responsible for electronic components, circuit design, and embedded software leading an international team Development of specifications Preparation and technical support from UL and CE approvals to EN60601 (medical electrical equipment) Planning of software projects, budgets, internal and external resources, and schedule tracking Buying of technical equipment and engineering services Development and design of electronic components for medical devices (in particular blood donation equipment and blood processing in the medical-care environment) Programming of software for embedded systems (microcontroller: ARM7, PIC; software development according EN62304 class B / C Live supporting systems) EMC examination and approval of medical devices Technical support in the 510 (k) approval for U.S. FDA Technical support for FCC approval as well as testing of medical devices in accordance with the following standards: ANSI Standard ANSI 63.4 / 47CFR15.105 / 15 107 / 47CFR18 Product validation and verification, e.g. usability testing and application Development, design and documentation of test tools for manufacturing processes Creation of international production records for OEM manufacturing Training of international staff for the production of medical devices for OEM manufacturers during the ramp-up process International commissioning of medical devices and training of service personnel Security officer of manufacturing operations