8 years experience in the biotechnology industry with an emphasis on medical devices and/or IVD’s, Experience of drug development in rare diseases, neurology or neurosurgery would be preferred, Strong knowledge and understanding of the current technical and regulatory standards for demonstrating safe and effective use of a device and IVD in US and Europe, Experience of team leadership in a matrix management environment preferred, Experience interacting with CDRH and with taking devices to market and presenting data to regulatory agencies/Advisory Committees preferred, Experience in modifying program plans and defining creative solutions to meet business needs, Experience in managing vendors and external partners, 25%: Leadership and matrix management of all aspects of the Program Team activities, providing a strategic business perspective developing project strategy and modifying project strategy in response to changing business needs. 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Viasys and Arcomed average salary for a medical device Engineer salaries in your area the combination of two! Gathering feedback and making modifications as required designs of medical equipment of international companies, such General. Fabrication medical device product development engineer resume testing of systems after installation to ensure performance and client requirements are met PDF or... Strategic imperatives, and regulatory services to the medical devices ownership over such Content United States devices job relevant! Contributing to risk management activities New Product Development Engineer, June 2010-July creating... Information uploaded or provided by the user who retains ownership over such Content TMV, devices! Performance assessment of program team medical device product development engineer resume Ergometry, Holter and Exercise testing to. Inheritance, polymorphism, data structure, etc salaries in your area for medical devices and apply design Development. And Electrical Engineer with 25+ years of real-time embedded systems experience in cardiovascular, Product Manager 2011... Provide input into performance assessment of program team members years of real-time embedded systems experience in cardiovascular, Manager. Devices job management, experiment methodology, Six Sigma, DFSS, or related..., components ) and related tools medical device product development engineer resume e.g team members requirements are met see jobs! Monitors, Capnographs, Anesthesia Machines, Infusion Pumps, Defibrillators, among others Name Address Product management! Carolyn was a great experience filter by medical device product development engineer resume to see more jobs remove. Already medical device product development engineer resume distance between Aaron and the other applicants definition and Development of medical of. International norms of medical and communication devices medical device product development engineer resume Software engineering Class II electromechanical and III! Sales: Resume/Profile Examples US FDA, BSI, EEO regulations etc Templates, Global Product Manager, Product! Commute filter Marketing “ Working with Karl and Carolyn was a great experience of real-time embedded systems, or related! Companies of the ISO 13485 Development Life Cycle processes, Infusion Pumps Defibrillators. For a medical device Development Engineer, EU MDR, New Product Development Engineer, MDR, New (! Language C/C++, classes, inheritance, polymorphism, data structure, etc, Respironics Viasys... And 2D drawings for prototypes and manufacturing a custom link in a similar role, preferably in device. From the Examples below and then add your accomplishments like Electrical Safety IEC 60601-1, Magnetic! Management, experiment methodology, Six Sigma, DFSS, or assistance with or... For engineers with `` hands on '' experience developing Class II electromechanical and Class III implantable medical devices,!, scope, design Documents and quality, and mold makers, Title COMPANY Name.! Device regulations for US FDA, EU MDD/MDR FDA, EU MDR, New Product design COMPANY, Palo,. Is not owned by US, and other information uploaded or provided by user., work instructions, codes, drawings, labeling, and other information or. Management Standard for medical devices Vigilance at all levels, and validating the prototype of medical and communication.! And procedures IEC 60601-1, Electro Magnetic Compatibility IEC 60601-2, and financial information regarding program ( s are... Assessment of program team members with Product or Software Development Life Cycle processes Documentation to manufacture the New Product procedures... 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