Berlin, Berlin, Germany
Engineering Leader | Innovation & Product Development | Medical Devices | Polymer Engineering | Project Management I am an accomplished engineering leader with over 10 years of experience driving innovation in disposable medical devices and advanced manufacturing. My expertise spans system architecture, project management, and technical leadership, with a proven ability to mentor teams, foster collaboration, and communicate effectively across global organizations. Throughout my career, I have successfully led cross-functional teams and delivered complex R&D and industrialization projects across Europe, Asia, and the US. I specialize in: Project Management & Core Team Leadership Polymer Expertise & Material Selection Design for Manufacturability (DFM) Design for cost sustainability Verification & Validation (V&V) CAPA Ownership & Quality Systems Statistics Expert (MSA, DOE) with advanced analysis using Minitab Concept Design & Review Supplier Chain Definition & Economic Feasibility Cost Optimization, COGS & LBM Estimations Regulatory & Standards Expertise: ISO 13485, ISO 10993, ISO 11137, ISO 11607, FDA 21 CFR, MDR, REACH, RoHS, ASTM Standards, AAMI Guidelines, and 510(k) FDA submissions. My work has delivered measurable impact, including 20% cost reductions through DFM strategies, robust validation processes, and optimized supply chains. Certified in Lean Six Sigma and Design for Reliability, I combine technical depth with strategic vision to align product development with business goals. Passionate about mentoring engineers and driving sustainable innovation, I thrive in regulated environments and aim to shape the future of medical device technology through leadership and collaboration. Let’s connect if you’re looking for expertise in innovation management, technical strategy, or global product development.
The lead system architect disposable is responsible for the development ofa platform for pump and insufflation tube set NPIs. The lead system architect disposable is also responsible for the technical further development of Disposable Competence Center. Primary Responsibilities: • Evolve and maintain a development platform for disposable tube sets • Define architecture of complex tube set systems based on AFR (architectural feature request) • Technical control of the technical project components and content- related support of the associated work packages (goal definition, DoD) together with the project manager and the R&D team • Responsible for meeting all relevant standards and requirements. • Design, optimization and documentation of the system architecture of disposable tube sets, considering regulatory and normative provisions (mainly for basic and technology developments) • Creation of system specifications as part of the specifications phase • Responsible for risk management • Monitoring technical development progress • Responsible for standard testing of the device • Creation and maintenance of technical documentation for your own area of responsibility • Technical contact for customers and external development partners • Technical support for sales in project acquisition • Technical Mentor | Go-to Expert for Junior Resources
As Product development inside of the R&D engineering area, I playing R&D Engineering interface with others others department, structuring design concept activities inside of the engineering, driving the concept development and implementing design changes on the products.
Biomedical industry, design and improvement of dialysis machines and accessories