Amit Keren Email & Phone Number

Israel

Energy Based Medical Device for dermatologic and Aesthetic indications. Overseeing Skin Products Portfolio.

Israel

End-to-End product ownership of Lumenis flagship Stellar M22, a multi-application platform offering 30 clinical indications utilizing 4 diffrent light and laser technologies.

Haifa District, Israel

In-vitro diagnostics: Own new products exploration. Translating market insights into strategic planning.• Directing strategic analysis, leveraging diagnostic gaps and clinical pain-points into new business opportunities, steering MeMed’s product development pipeline.• Structuring Market Requirements and Voice of Customer insights into actionable product specifications, ensuring alignment with market demands and customer expectations.

Haifa, Israel

In-vitro diagnostics: Leading complex, multidisciplinary R&D programs involving HW, SW, biochemistry, and machine-learning.• Successfully led the MeMed BV® Whole Blood development program from early feasibility to regulatory clearance: IVDR & 510(k) (K230944). • Coordinated a prospective, multi-center sample collection study for evaluating the analytical equivalency of serum and whole blood samples run on the MeMed Key® platform. Including 5 clinical sites (IL and US) and >250 patients recruited. • Led a SW upgrade program to support whole blood sample type commercialization efforts. Completed and implemented globally - 2 months (20%) ahead of schedule.

Qaesarea, Haifa, Israel

Cardiovascular: Innovation group leader responsible for new technologies explorations and proof-of-concept projects. Direct collaboration with Venus MedTech KOLs and executive management (China).• Pursuing innovative solutions for interventional cardiology pain-points. Collecting and analyzing VOC.• Managing a cross-functional global team of R&D, OPS, RA, IP, Clinical - executing rapid development iteration cycles from user needs to ideation to prototyping. Leading hands-on ex-vivo experiments.• Directed technology transfer projects to engineering and biomedical research teams in China.

Israel

Surgical Robotics: Startup core team (company’s 5th employee) responsible for development of the HandX™ platform. A laparoscopic handheld electro-mechanical surgical robotic system.• Successfully led a global product development project of a Class II, disposable, sterile electrosurgical instrument through all development stages. Ideation to regulatory clearance: CE & 510(k) (K203603).• Focal point for all development activities under ISO-13485 and FDA 21 CFR part 820 design controls.• Managed a cross-functional global team of 14 professionals (IL, US) including engineers, QA, RA and OPS throughout product realization and validation activities, including compliance with electrical safety standards (IEC 60601-1-1; IEC 60601-1-2; IEC 60601-2-2).

Israel

• Sr. R&D Mechanical Engineer at the HandX™ platform development from concept through minimum viable product feasibility, V&V and regulatory clearance: CE & 510(k) (K173919).• Managed a global Design for Manufacturing (DFM) and cost reduction program using advanced production technologies with strategic contract manufacturers partners in Israel, Taiwan, US, India.

Israel

• Part of a small team responsible for research, design and development - from Concept and Feasibility [C&F] stage to a successful CE and FDA (510K) submissions• Implementing Design for Manufacturing [DFM], Design for Assembly [DFA] technics and technologies for the disposable instruments program includes: Advanced CNC manufacturing, Laser Welding and Cutting, Metal Stamping, Heat-Staking, Plastic Injection Molding, Silicon Pressing and more• Responsible for manufacturing process development and Design Technology Transfer to initial V&V production

Israel

Consumer Electronics: Part of mechanical team responsible for design and development of N-trig's active stylus program, an electro-opto-mechanical product, from concept to mass production.• Successfully delivered 4 design projects to commercial production including: "Microsoft Surface Pro 3 Stylus" and the "Sony VAIO Stylus" (in several stylus models).• Collaborated with customer global product experts and subject-matter experts on Marketing Requirements and Product Requirement to ensure comprehensive and aligned product specification.• Supported Microsoft’s technology transfer and production line development to a tier 1 ODM (Taiwan, China), including multiple onsite visits.• Led a product cost reduction project resulted in a ~40% reduction availability.

Israel Defense Force: Unit 81 - Technology Unit, Military Intelligence Directorate