The Senior Solutions Architect-Mechanical, R&D Hardware & Embedded Solutions 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
5-8 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
