Bavaria, Germany
With a proven track record in scaling up Development teams, I bring expertise in medical device development, embedded systems, and functional safety to my leadership role. With a successful history in people management and technology transformation, I have led the development of Electronic HW and SW of a heart-lung machine from concept to certification. Drawing on my experience in entrepreneurship and my background in semiconductor and high safety industries, I am a driven, independent thinker with a passion for innovation.
- Team Scale-up and Set-up (from 1 to 30 SW Engineers) - Setup of up-to-date SW Development processes and tools (Agile, CI/CD, Test automation) - SW Development (up to 17 SW SW subsystems) according to Class C - IEC 63304 for 4th Generation Heart-Lung-Machine - Product certification according to IEC 60601-1, IEC 62304 and FDA guidelines
Managing the Embedded HW/SW team on the development of new Heart-Lung-Machines: a) Set-up of the Embedded HW/SW Team; b) Team building and increase Team awareness; b) Introduction of Agile methodologies to approach complex challenges; c) Interface role with strategic external suppliers; d) Interface with other departments and Project Manager
New Product Development for HLMs (Heart-Lung Machines) and medical devices used in cardiac surgery or cardio-pulmonary diseases: a) Project Management: successfully managed the development of Heart-Lung-Machine's accessories; coordination of activities among different departments; interface with external suppliers; project delivered on-time and on-budget. b) Design Control for FDA certified medical devices (EN ISO 13485 / IEC 60601)
HW/FW Development and product design support for a highly integrated Bluetooth 9-axes motion detection system.
Development of new products based on Wireless Sensor Networks interacting with Web&Mobile Applications: IsiMobi - The Social Smart Mobility System (www.isimobi.com): a) Fund-raising: participation to StartUp contests, Company presentation, Due Diligence negotiation. Received an investment of 80.000€ from investors; b) Business Plan and Product Strategy development: market and competition analysis; technical and economical feasibility analysis; business model analysis and strategic positioning; product requirements definition. b) Electronic Design (Hardware & Firmware) of the Wireless Sensor Network and System integration; algorithm design. c) Project Management: Project Plan development, managed a team of 4 people and external suppliers d) CE marking and product industrialization; e) Relationship with suppliers & customers.
IsiCity is a Web&Mobile Platform that helps citizens in cooperating with the City Administration for better controlling the urban area and solving practical problems. My role in the project is as CEO and Project Manager. a) Fund-raising: participation to Principi Attivi StartUp contest. Won a 25.000€ grant. b) Project Management: Project Plan development; team managment; relationship with external suppliers. Project concluded on-time and within budget.
Sintesi SpA produces high-tech industrial automation equipment. Sintesi SpA has now sold its IP to 0n3 s.r.l. (EXOR Internationa SpA - www.0n3.eu) I've been involved in the whole project life-cycle of Sintesi's Safety Mobile devices for controlling Robots and industrial machines. Main activities: a) Electronic design: HW, FW and PCB Layout design of Electronic Boards integrated into “Safety certified” wireless controllers for the industrial automation. uC programming (Microchip and Freescale uCs). Experience on consumer and industrial protocols (CAN, I2C, SPI, Bluetooth, WiFi). First prototype ready for production. b) Embedded system development: components'selection and validation, relationship with international suppliers, interface with mechanical and embedded software developers, integration of mechanical and electronic components, product industrialization. Contributed to product cost-reduction (20%). c) Product certification: Study and analysis of Industrial Safety norms (EN 13849) and EMC norms (EN 61000). Development of Risk Analysis documentation. Product accomplished CE and TUV certification (SIL 2).