Stanislav Kramer Email & Phone Number

• Professionally manage and lead the mechanical engineering team in developing multidisciplinary systems. Assume responsibility for all team activities.• Supporting all activities in product design process / design control – development plan, design requirement specifications and reviews, product risk analysis, product verification protocols, and transfer to production.• Responsible for compliance to medical device regulations and practices ( ISO 13485, FDA §820, IEC 60601-1 etc.) • Leading the quality processes and activities, covering all quality aspects related to supplier control, process control and improvement.

Main objectives and activity: • Drive system Vision, Architecture and Block Diagram.• Create the high level System Specification by merging the inputs from all stake-holders (SBU, Service, QA, RA, CA, OPS, R&D). Define system performance level.• Manage risk retirement and feasibility prove-out. Consider all technical alternatives. Participate in CAPA activities.• Drive requirements traceability and design review process.• Define Subsystem Interfaces.• Drive the Integration plan and follow-up on the related activities• Drive design for reliability, manufacturability, serviceability, performance, cost and development time. • Ensure Verification & validation of requirements : traceability (System level).• System Design Coordination. • Transfer the product to Production, assistance to the Engineering group• Sub-contractor’s management and follow-up.

Direct Engraving, Flexographic Printing Solutions Jan, 2008 - Sep, 2012 • Responsible for the Flexcel Direct auxiliary systems. • Coordinating activities of international subcontractors and staff with collaborating suppliers, working closely with customers, and managing stakeholder expectations. • Assessing requirements and editing documentations such as system requirements, statements of work, technical specifications and site preparation documents. • Covering engineering, quality assurance, training, acceptance testing, staging and production issues.• Cooperating with project members in mechanics, electronics, product support and safety teams to specify and continuously improve the auxiliary systems. I served as a technical product expert, manage technical escalations and am responsible for delivering solutions to the customers, including troubleshooting and debugging of problems found in field installations. May, 2006 - Dec, 2007, 4-Page CTP Products Offset Commercial Printing • Responsible for the complete design process (from concept to production), including requirements specification, feasibility studies, cost and scheduling. • Conducting various analyses, such as structural, fluid, thermal, and FEA modeling. Performing conceptual and detailed design using CAD systems (Solid Works), detailed drawings and preparing design review presentations. • In charge of procurement of prototype parts, system integration, prototype testing, and handoff to manufacturing. • Developing the required supporting documentation such as assembly and test procedures. • Supporting activities related to manufacturing, continual improvement and cost reduction.

CINTEC MEDICAL LTD., manufactures mammography and biopsy systems used for early detection of breast cancer.Product development and ongoing support for Fully Automatic Mammography System.• Component, electro-mechanical system and mechanism design and analysis. Utilize CAE / FEA, modeling, and design optimization techniques. • Coordinating the production of drawings packages for the manufacture of Mammography System and its integrations. Generation of Engineering Change Orders to improve designs, modify BOM's, increase efficiency of operations.• Provide technical support to purchasing department. • Collaborating with quality manager, operation manager, subcontractors.

M.Sc., Mechanical Engineering Combined With The Mba Program

Activities and Societies: Through the coursework for the degree, I have reached the skills needed to work at a managerial level.

B.Sc., Mechanical Engineering

2002 – Dean's awards for the excellence.