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Medical Device Design Engineer

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Last Updated: 02 July 2021

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Highly regarded global Medical Devices company is searching for an R & D Mechanical Design Engineer to lead Product development activities for the new electromechanical Medical Device platform. The R & D Mechanical Engineer will be responsible for Mechanical life cycle Engineering, from concept through launch, and post development support for new products, leading overall Product Design as well as component Design. Requirements For R & D Mechanical Engineer-Medical Devices: Bachelor's degree in Engineering, preferably Mechanical Engineering, advanced degree prefer 7 + years experience in Design of complex mechatronic systems, Class II electro-Medical Devices. Working Experience modeling with computer aid Design software: solid and surface modeling ability to work with Product development team members in Europe. Strong understanding of cross - cultural, international product development strongly prefers understanding of Product Data Management system Experience with reliability testing methods and principles. Working Understanding of IOT Experience with tolerance stack-up Analysis, static FEA and fatigue Analysis. Knowledge of geometric dimensioning and tolerancing GD & T knowledge of Design Control process following ISO13485 or FDA 21 CFR 820 Design Control Guidance For Medical Device Manufacturers R & D Mechanical Engineers will: Design and develop Mechanical parts and assemblies for new Medical Device platform. This will include overall product design, as well as components of the device. Prepare / approve Mechanical development documentation, including Product requirements, Design specifications, and verification and validation protocols Design 3D models and prepare design drawings and layouts for new products and components, such as cosmetic injection mold parts, structural and motorized assemblies, sheet metal components. Responsible for ensure that product development and design changes conform to the requirements of Design Control procedures. Work with R & D team members in the US as well as Europe. Provide technical support for new product manufacturing requirements. Manage project plan to meet established schedule and cost targets. Conduct / supervise verification and validation testing, and document testing results. Evaluate and implement improvements to product designs and manufacturing processes. Develop, review and approve Engineering change orders, considering improvements to quality, cost, customer requirements. Develop, document and lead product and / or process pilot runs and validations for new products. Develop estimates for capital requirements to support products and prepare CERs as necessary. Analyze, implement, and document design modifications required to improve product reliability. Participate in Risk Analysis and implementing Risk mitigation

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Facets of Medical Device Design

Design and development of medical devices is the most crucial phase for its success. Loosely-define and designed medical devices cannot comply with regulatory needs and make it to market. Or just in case, even if it passes compliance, it will fail to deliver defined functionality and benefits, according to market needs and suffer from lesser market adoption compared to well-design products. Spending hours with Medical device developers and studying multiple Medtech projects, including allergic Drug vending machine, software control insulin pump, endoscopy device miniaturization and much more at eInfochips, now I understand that Medical device design and development is more than just conceptualizing solution,sss developing prototypes and mass manufacturing them to sell.


Product Ideation and Conceptualization

Once you are do with product definition and idea, you need to consider procedures like FDA defining classification and Intellectual Property rights. Medical device classification is based on risk associated with use and enforced by law. Also, you need to look for any pre-existing Intellectual Property on propose idea or similar; it might actually disallow you to use mechanism or technology. To carry out the complete discovery phase, strong development team is crucial. This may be a pitfall if the team is not well experience. In any case, you can decide to go with an in-house team, consultant or company to get help with medical device engineering. Whatever option you choose, team needs to be experts in the following areas: engineering and design Human factors and usability engineering, Clinical and scientific knowledge of medical industry, Regulatory affairs and quality assurance, Intellectual Property law

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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