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Job Summary:
requires in-depth knowledge of documentation of new product design & development of medical devices, using SolidWorks tool. Typical job responsibilities include (but are not limited to) working with the product management groups from both local & global locations to understand the build of the test article, analyze, interpret and modify 2D and 3D engineering drawings and build models.
Essential Duties and Responsibilities:
• Possesses understanding of the complete solution offering from requirements, design document, Resource estimation, Material selection, Creating complex simulations & Risk Analysis
• Knowledge of medical standards such as IEC13485, 43 FR 31 508
• Preparation of SolidWorks drawings and models.
• Proper interpretation of design specifications, standards and drawings and follow-up with vendors to convert into a product.
• Preparation of instruction and operation manuals
• Builds and maintains strong relationships with the team and business to ensure collaboration and alignment within and outside of the division.
• Using knowledge and expertise, solves problems, recommends architecture and processes, recommends changes to existing architecture and processes, and also exceptions to architecture, technology, and process standards globally.
• Helps drive agile and DevOps culture of implementation and product management culture.
• Other duties as assigned
Education and Experience:
• Bachelor’s degree in Mechanical Engineering. Post-graduation in Design Engineering / Industrial Design is a plus
• Minimum of 6+ years of related work experience .
Knowledge, Skills and Abilities:
• Expert in the use of SolidWorks tool
• Knowledge of medical standards and practices such as IEC13485, 43 FR 31 508, GMP
• Good design skills supported by simulation using FEA, MATLAB or similar mathematical modelling.
• Good knowledge in materials, processes and sources applicable to medical devices
• Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment
Physical and Travel Requirements
• Up to 20% travel may be required
• Occasional on-call work required
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