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You will be responsible for driving meaningful and innovative product development, generating ideas/concepts in feature development to improve quality and reduce cost, as well as performing the role of a technical lead in taking the product development through manufacturing release while transferring products between suppliers and manage sustaining of different devices by following PDLM-MLD process.
To be part of an exciting team and contribute to the design, development and maintenance of Diagnostic Imaging (MRI, CT/AMI, DXR etc.) components and products. In this role of, you are responsible for the development and maintenance of Image Acquisition Platform (IAP) - Hardware Systems/Subsystems and will gain substantial knowledge of complex systems in medical imaging environment. Together with a multidisciplinary team of engineers, you play a crucial role in getting these systems/sub-systems to the required performance, by understanding the electrical, electronics and controls and looking for the best solutions within those boundaries. This requires broad orientation, conceptual skills and a “can do” mentality, keeping abreast with all trends and
You are responsible for
Leading the development and release of system/ electro-mechanical modules or reverse engineer existing products to improve overall long term system quality, reliability, yield rates, and cost effectiveness.
Working with a cross-functional team to ensure the design and development of electro-mechanical components to meet the needs of the internal and external customers.
Working with design partners/suppliers and lead product development activities from design concept to manufacturing release.
Using modelling and simulation tools to create and modify architectures, 3D designs, and 2D drawings.
Drive continuous improvement projects related to design implementation, manufacturing process, product quality and reliability.
Requirements, design, implementation, test and integration of module/sub-system in accordance with the higher-level architectural requirements and design specifications
Ensuring that the design is consistent with the higher-level architecture and requirements
Ensuring that the proposed design would have the safety, reliability and quality features built-in
Responsible for ensuring that the design meets the performance, quality and cost criteria
Conduct concept and feasibility studies. Leads the introduction of new technologies
Ensuring that there is proper documentation per standards for the developed design
Ensuring the mutual consistency and efficient integration of the separate components in modular design that meets the product specification
Ensuring that his design modules meet the product certification requirements
Drawing up personal schedule and reports on progress
Defining and assessing the Work Breakdown Structure/planning/costs of his/her area
Being abreast of technical developments in own field through study of literature and technical contacts
Maintaining product and company reputation by complying with country specific regulations
Supplier evaluation and communication
To succeed in this role, you shou
M.Tech / B.E/ B.Tech in Mechanical/ Electrical/ Electronics or Equivalent Engineering
10+ years of relevant experience in design & development of electro-mechanical sub-systems & systems.
Strong communication and collaborative abilities proactively seeks out expertise and advice and input from others in a collaborative team-environment.
Experience in developing the requirements for electro-mechanical assemblies.
Knowledge in part qualification and statistical process studies such as CP and CPK and be able to work with suppliers to improve part process capability.
Experience in lifecycle testing and verification activities of cables to meet functional and lifecycle requirements.
Experience working with suppliers and design partners, including part/module development and resolving technical issues.
Strong technical writing/ documentation skills for regulated medical device design environment, including requirements definition.
Knowledge of good design practices and experienced with DFMEA.
Knowledge of EMI/EMC standards and testing for conformance
Knowledge of mechanical design compatibility aspects
Knowledge of IEC 60601 standards will be an added advantage
Knowledge of Embedded Software Programming will be an added advantage
Ability to understand and debug problems across hardware/software boundaries
Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE, CSA etc.
Demonstrated ability to effectively work with cross-functional stakeholders to ensure the design meets their expectations and needs, and that the needs/requirements are properly documented.
Experience with document control systems (E-Matrix, Agile) and FDA/ISO regulated medical device design environment.
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