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.

• 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.

• 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.
• 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 and.

B.Sc., Mechanical Engineering

2002 – Dean's awards for the excellence.