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Experience including at least two of the following: digital and/or modern control systems, dynamics, Kalman filter design, Monte Carlo, development and/or simulation of physical systems, or signal processing.
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Bachelor or Master of Science degree in Mechanical or Mechatronics Engineering with 7-10 year’s experience in the design, development and launch of complex electro-mechanical products. Experience in machine design that has incorporated machine elements, mechanical drive systems, sensors, kinematic principles and/or mechanisms, electro-mechanical packaging, design for cost and manufacturability.
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Serve as QSP modeling & simulation point-of-contact in multidisciplinary project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of data.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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This role is suited for an R&D engineer with experience in developing, building, and testing complex electro-mechanical medical devices, design transfer, and process validation with broad knowledge of electrical, mechatronics, firmware, software, and systems engineering, including design verification testing, and transfer to manufacturing within a regulated medical device development environment.
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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Oversee in vivo and in vitro studies, including development and optimization of disease models, study design, data collection, and interpretation. Collaborate closely with cross-functional teams (molecular biology, bioinformatics, clinical development) to achieve integrated research objectives.
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Contribute to the development of a healthy product backlog, collaborating with the Product Manager, Engineering, and Solution Architects to break down business epics, document user stories (to also include things like addressing technical debt, SRE, etc.
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Supervise the development and deployment of Robotic Process Automation (RPA) and PowerApp solutions to digitally enhance operational efficiency. Develop and enforce best practices for IT infrastructure management, including disaster recovery, data storage, network design, and cloud services.
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Embedded software and application development and design of associated software architectures. Implement embedded software with digital signal processing algorithms including driver development and driver integrations.
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Minimum of 5 years experience in developing, building, and testing complex electro-mechanical medical devices, design transfer, and process validation with broad knowledge of electrical, mechatronics, firmware, software, and systems engineering, including design verification testing, and transfer to manufacturing within a regulated medical device development environment.
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Proficient in design and development of PCBA test fixtures and the related testing processes (requirements development, tester development, test protocol development, test execution, test report), ECO documentation for test fixture.
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Design, plan, and implement creative and innovative student-centered lessons which demonstrate a deep understanding of the academic discipline, curriculum, instruction, child development, and best practices, aligned with the goals and mission of The Park School.
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Participate in strategy, design, authoring, and review of clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plans.
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Understanding of basic functionality and how the circuit designs interface with SW and FW. Experience with the following design and simulation tools: Siemens Designer and Layout, Hyperlinx, Ansys, Spice, Matlab) Experience with miniature electronic packaging and design using bare die or chip-scale packages.
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development design jobs in Needham, MA
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