Overview:
Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. The below client is with one of our client which is a leading global medical technology company. It offers a wide range of diagnostic imaging and laboratory diagnostics as well as advanced therapies and digital health services. Its solutions span from prevention and early detection to diagnosis treatment and followup care empowering healthcare providers worldwide.
Job Title: Sr Design Readiness Engineer (Contract)
Location: Newton MA 02466
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift Timings: 8:30am to 5:30 pm
Position Summary:
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The Senior Design Readiness Engineer will be a part of the R&D organization and an important contributor to the realization of the next generation robotic platform that will change the future of healthcare.
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You will be a highly visible technical resource working on the transition of complex electromechanical assemblies from prototype to verification builds and testing in close collaboration with manufacturing engineering.
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This role is suited for an R&D engineer with experience in developing building and testing complex electromechanical medical devices design transfer and process validation with broad knowledge of mechanical mechatronics firmware software and systems engineering including design verification testing and transfer to manufacturing within a regulated medical device development environment.
Key Responsibilities:
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Being a key team member working on design readiness of the robotic system
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Support development of assembly and test processes
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Support identification of specification creation for development and characterization of inline test and build fixtures
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Support development and maintenance of the BOM and DMR
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Specify firmware and software development requirements for test and build fixtures
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Author relevant documents such as build process assembly instructions inspection procedures test protocols test reports analyses and system documentation
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Support a variety of multidisciplinary technical and process improvement projects of different sizes and scopes
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Help with the vendor communications and procurement issues
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Support creation of DHF and release of documentation to quality system
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Manage and communicate assigned projects in collaboration with crossfunctional teams
Qualifications:
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8 years electromechanical R&D engineering experience at least 5 years in medical device required
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Bachelors degree in Mechanical/ Robotics/ Mechatronics/Advanced Manufacturing Engineering or a close field is required
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Deep understanding of DFM (Design for Manufacturing) DFA (Design for Assembly) and DFT (Design for testing) required.
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Experience in managing engineering projects required
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Expertise with firmware and software within electromechanical systems is highly desired
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Knowledge of PCBAs (understanding the design testing and documentation) is highly desired
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Must have previous experience in design transfer/new product introduction
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Must have indepth knowledge of design verification of complex medical devices
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Must have deep knowledge and working experience of medical device design control
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Indepth knowledge and experience in transferring design to manufacturing is required
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Experience in offthe shelf component selection for regulated industries highly desired
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Experience with statistical tools and software such as Minitab and MATLAB desired
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Able to execute assigned projects and duties with minimal supervision
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Outstanding documentation and communication skills required
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Proficiency in using MS Office and Solidworks required
TekWissen Group is an equal opportunity employer supporting workforce diversity.