R&D Eng - P4

Develops new technologies, products, materials, processes, or equipment with minimal supervision. Responsible for designing, defining and implementing system requirements for complex customer systems and/or preparing studies and analyzing existing systems. Develops technology, product designs, testing of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation. Leads product improvement design activities Designs, coordinates, and analyzes complex engineering tests and experiments. Develops slide decks & reports and presents updates to management & technical community. Influences middle management on business solutions. Interfaces with Marketing and/or field personnel to obtain feedback on concepts and performance of new devices. Translates customer needs into product requirements and design specifications. Partners with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure success. May train and/or provide work direction to technicians and entry-level engineers. Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. May lead projects within the function or department and/or represent a specialized field in larger project teams. Uses discretion, diplomacy and tact to resolve difficult situations. Conducts root cause analysis of design related field complaints Support RA team with new markets registrations and regulatory submissions. Designs, defines, implements system requirements, system specifications, input/output processes and working parameters by using current systems engineering methods and technologies. Documents system requirements by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards. Tracks system engineering effort by creating and maintaining records in the approved tracking management tool. Solves system problems by analyzing the situation and recommending corrective or alternative actions. Analyzes, coordinates system partitioning (i.e. hardware/software partitioning) and total system integration by using systems engineering practices. Conducts special studies on subjects such as improving systems engineering practices, improving system quality, subsystem partitioning, etc. by researching and analyzing options for implementation. Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes. Directs support personnel and project activities. Mentors engineers in software engineering activities/methodologies and domain knowledge. B.S. in Mechanical or Biomedical Engineering preferred with 5+ years related work experience or an equivalent combination of education and work experience Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines. Ability to identify and solve problems with root cause analysis, including designing and executing experiments and using statistical methods to drive data-based decisions. Experience designing and evaluating test methods and fixtures. Ability to work hands-on with test systems and develop new test systems as needed. Working technical knowledge of implantable medical devices. Experience with commercialized product data management systems. PE licensure preferred; a minimum of EIT certification desirable. Fully Bilingual