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Develop innovative medical device solutions that meet industry standards and regulations such as FDA, IEC, and ISO. Knowledge of industry regulations and standards, such as FDA, IEC, and ISO.
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Engineering and delivering automation solutions from device to monitoring and control make our customers get more out of their investment; digitalization solutions including collaborative operations and augmented reality help improve plant and enterprise productivity, reduce maintenance and energy costs.
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Technically lead the development of medical device electronics. You will be responsible for developing innovative medical device solutions that meet industry standards and regulations. Expertise in the latest software tools such as Altium, ORCAD, Cadence, Allegro, and Spice to create schematics and prototypes.
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Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions related to high reliability critical care medical devices. The Electronic Design Engineer is responsible for the electronic design and development for use in critical care medical device products.
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The Electrical Engineer will need to be 7+ years in medical device (preferred) along with the following areas of need: Medical 60601 Safety/EMC/wireless coexistence. This position would be supporting a robotics group of a large medical device client on a high visibility project This is supporting the robotics engineering team.
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You should have knowledge of regulatory requirements that may affect a design such as ISO, UL, and IEC. Experience in medical device development specifically is a strong plus. You will be responsible for the design and development of complex electromechanical, electronics-based, and embedded systems-based products.
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Use IEC (International Electrotechnical Commission) 61131 programming languages, configuring associated HMI terminals, designing field communications with a variety of industry standard bus protocols and applying an understanding of Ethernet networked devices to design control related networks.
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Must have familiarity with Good Manufacturing Practices (GMP) Preferred: Familiarity with ISO, IEC, and other standards pertaining to the medical device industry. Must have the ability to read and interpret technical drawings, schematics, and documentation related to medical device manufacturing Preferred: Proficiency in CAD software (Fusion 360) and GD&T.
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Fasikl has obtained two simultaneous FDA Breakthrough Device Designations for its implantable systems, with MindForceTM Nerve-Computer Interface (NCI) admitted into FDA’s Total Product Life Cycle Advisory Program (TAP.
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As a Senior Systems Engineer -Technical Lead you will serve as the technical lead on our most complex new product development projects. You will be responsible for the technical success of a project team in the design and development of complex electromechanical, electronics-based, and embedded systems-based products.
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Modelling and developing electrical systems throughout the device, such as, stepper and DC motor control, AC power systems, low voltage data, and high sensitivity analog and digital signals. Knowledge of IEC safety and EMC standards and experience in working with regulated test labs.
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Familiar with medical standards (ISO, IEC, AAMI, ASTM, etc.) Primary Talent Partners has a 2 year contract opening for a Test Engineer to join a multinational medical device company for an onsite position in Lafayette, CO.
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Preparing specifications and drawings, including equipment/device data sheets, loop diagrams, instrument index, wiring diagrams, single line diagrams, panel wiring diagrams. Knowledge of engineering standards in oil and gas/chemical industries, such as API, ISA, IEC, NEC.
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Provides QA guidance and support throughout the entire design control and product realization processes to ensure that medical device/products meet all applicable regulations and standards (e.g., ISO13485 requirements, 21 CFR Part 820, other applicable FDA regulations and guidance documents, applicable ISO and IEC standards, and regulations of applicable global regulatory authorities.
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Using IEC (International Electrotechnical Commission) 61131 programming languages, configuring associated HMI terminals; designing field communications with a variety of industry standard bus protocols; applying an understanding of Ethernet networked devices to design control related networks.
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