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Drive product development activities in compliance with regulatory requirements, including FDA regulations, ISO, IEC, and other standards. 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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Authors, reviews, and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions. · Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.
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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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Experience with FDA, ISO, and IEC standards a plus. Experience with FDA, ISO, and IEC standards a plus. Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance.
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Knowledge of FDA, IEC and UL standards relating to medical devices. Advanced training in project management and PMP, ACP, SAFe and/or Six Sigma certified strongly preferred. Knowledge of FDA, IEC and UL standards relating to medical devices.
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Documentation, including schematics, wire harness drawings, PCB files, and component specifications for FDA processes. Knowledge of IEC safety and EMC standards and experience in working with regulated test labs.
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Must have experience with applicable manufacturing processes such as injection molding, thermoforming, machining, and plastics assembly. Must have expertise with SolidWorks CAD software. We are seeking a Senior Mechanical Engineer for our client.
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Perform structural, dimensional, fluid, vibration, thermal, and reliability analyses to support new and existing product designs. Document designs by constructing solid models, assemblies, and drawings with SolidWorks.
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Experience with ISO, IEC, and FDA regulatory requirements for 510K submissions related to high reliability critical care medical devices. Knowledge of FDA electronic design documentation and test requirements for 510k submissions.
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Prior experience developing FDA approved medical devices. Expertise in the latest software tools such as Altium, ORCAD, Cadence, Allegro, and Spice to create schematics and prototypes. Expertise in circuits, digital and analog design, EMC, and microprocessors to ensure our products meet industry standards.
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Advanced training in project management and PMP, ACP, SAFe and/or Six Sigma certified strongly preferred Knowledge of FDA, IEC and UL standards relating to medical devices. Advanced training in project management and PMP, ACP, SAFe and/or Six Sigma certified strongly preferred Knowledge of FDA, IEC and UL standards relating to medical devices.
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Working knowledge of ICH/GxP guidelines, FDA, MHRA, EMA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements. This position will closely interface with Clinical Operations, Quality, CMC, Regulatory, CDMOs and CROs to ensure clinical/investigational material is available as required to achieve clinical trial strategy and program timelines.
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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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Job Title: Senior Mechanical Engineer – Sustaining Engineering. BSME with 8 years or MSME with 6 years mechanical design/engineering experience or equivalent combination of education and experience. Write test protocols and reports in support of product and process verification/validation.
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Experience with electrical medical devices and associated IEC standards. Provide regulatory affairs support during FDA inspections and Notified Body audits. We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system.
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