Clinical Systems Engineer

Clinical-Systems Engineer (actual title commensurate with level of experience) Think saving lives sounds like a satisfying purpose?  Join Clinical-Systems Engineering at St. Jude Medical, to build life-saving medical devices from inception through implementation.  As part of the Clinical-Systems Engineering organization, you will be responsible for driving product development of an entire cardiac rhythm management system from a technical perspective and will be responsible for aggregating design input from multiple stakeholders such as Marketing, Field Clinical Engineering, Sales Organization, etc. to define, at a high level, our future products, their interactions and behaviors.  Throughout the product development lifecycle, you will be responsible for providing technical, clinical and usability leadership to enable individual project teams to execute against the system vision that you have established.  By understanding the strategies of the individual design teams, you will ensure that the separate development efforts will seamlessly converge consistent with your system vision and our customers’ needs.  You will manage risk, identify and work around constraints, foster collaboration, evaluate technologies, motivate and inspire, provide guidance, remove obstacles and generally, do whatever else the team needs to do to insure we deliver the right products to market at the right time.   As the ideal candidate, you have outstanding written and verbal communication skills with experience defining products and ensuring they meet customer requirements.  You also have strong project management skills, are a charismatic leader and doer, and have a solid business perspective coupled with an understanding of the clinical and regulatory environments in which we work.  You are a team player and are comfortable working across boundaries.  Ideally, you also have some familiarity with multiple disciplines including hardware, software design and development.  Your previous work experience may include Product Management, Project Management, Consulting, Systems Engineering, Clinical Engineering or something similar. Essential Functions·  Investigates and defines clinical requirements for new algorithms, and facilitates the transition of algorithms into new projects through clinical review and evaluation.  Assesses the clinical and system risks of new algorithms and features, and identifies potential interactions with existing ones.  Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of new algorithms.·  Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications.  Participates in broad cross functional review of work output.  Updates and maintains feature specifications for one major project and may support one or more additional minor projects.·  Simulates or tests aspects of new projects or algorithms to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes electrogram, diagnostic or programming data collected from the field or from research studies.  Defines and conducts storyboarding/beta testing to evaluate/measure customer acceptance of proposed product performance and operational characteristics.·  Identifies and resolves issues, escalating as appropriate.·  Prioritizes tasks by distinguishing urgent from important tasks, and is able to manage time effectively based on priorities.·  Provides input into the development of clinical system validation plans, and the conduct of those tests.·  Collaborates with cross-functional teams to complete work.  Is able to successfully influence stakeholders within CSE.·  Keeps leadership informed of progress and issues. Qualifications:Bachelor’s Degree in Biomedical Engineering, a related field, or equivalent including relevant coursework and/or work experience in product development (especially definition and validation), cardiology and electrocardiogram interpretation. Typically a minimum of two plus years of relevant, progressively more responsible work experience in medical product development and/or graduate degree with relevant project.  The demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs is also required.  Requires demonstrated written and verbal communication, interpersonal, analytical/problem solving, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.  Must be able to handle multiple assignments.  Must be able to perform in a diverse cross-functional team environment.  Must have the demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks.  Must have demonstrated personal computer skills, be able to perform basic word processing/spreadsheet tasks to perform documentation, presentation, and analysis activities and be able to grasp new technical concepts and tools quickly Sound like fun?  Please send your resume in Microsoft Word format to Marshall Van Wormer (MVanWormer@sjm.com).   St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.