Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish
goals.
Impact this role will have on St. Jude Medical:
Facilitates meetings with Global Clinical Affairs leadership team to elicit, analyze, and document detailed clinical business requirements.
Makes appropriate recommendations for continuing, modifying, or abandoning proposed projects based on the results of feasibility studies and/or cost/benefit analyses.
Maps current processes to the desired state and identifies gaps such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls.
Performs clinical process analysis to define configuration requirements.
Balances needs and acts as liaison between the clinical organization and the technology areas necessary to develop solutions.
Develops clinical process flows and data models for new system development or for process redesign.
Provides solid test designs, develops test cases and reviews/approves the efficiency and execution of those test cases.
Coordinates all Validation activities for proposed applications, including creating Validation Plans, Validation Test cases, executing Test cases and creating Validation Final and Summary reports.
Contributes to, and manages execution of, end-user training as needed.
Provides support to existing applications and resolves clinical business and technical problems.
Performs technical system activities as needed.
Keeps informed of trends and new developments in technology to better advise management of means to accomplish clinical business and information systems goals.
Communicates effectively with GCA leadership to enhance their understanding of the opportunities and limitations of information systems.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Track and monitor clinical business development projects from initial screening through completion of integration and any milestones.
Support evaluation of new technologies and intellectual property.
Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:
Bachelor’s Degree in Engineering, Biological Sciences, a related field, or equivalent. An advanced credential is preferred.
Typically a minimum of ten plus years of progressively more responsible relevant clinical experience, with in-depth knowledge of cardiology, electro-physiology, and implantable cardioverter defibrillators (ICDs), pacemakers, or cardiac electro-physiology procedures. Experience in electrophysiology and experience with Electrophysiology procedures, Ablation procedures and advanced mapping techniques.
An advanced credential in a relevant discipline/concentration such as Biological Sciences. Professional Health Science certification or designation. Successful completion of the North American Society of Pacing and Electrophysiology (NASPE), Associated Professionals examinations in Electrophysiology and Pacing and Defibrillation. International Board of Heart Rhythm Examiners (IBHRE).
Experience working in a broader enterprise/cross-division business unit model preferred. Applies an extensive technical expertise and/or a thorough specialized knowledge at the forefront of the clinical engineering profession; applies, develops, and promotes advanced concepts and practices; recognized authority in field. A qualified record of developing/implementing new processes within the clinical engineering profession is a must.
Demonstrated delivery of new product development concepts. Consistent record of delivering research information which adds value to management’s decision making process.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Requires highly developed experience sufficient to assume responsibilities of multi-tasking, prioritizing projects, meeting deadlines, forecasting milestones within a budget.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Strong organizational and follow-up skills, as well as attention to detail.
Experience in Lean & 6 Sigma Methodology with strong record of optimizing workflows in prior positions.
Strong background in computer programming including but not limited to: SQL, Python, Matlab, C#.
Project Management skills.
Financial Modelling Expertise and strong analytical skills.
Strong bias towards self-checking quality control to deliver robust, reliable data. Precision and accuracy while being able to work with some level of ambiguity and data assumptions is a must-have.
Understand limitations of current systems and be comfortable to fill in with assumptions as appropriate.
Identify and prioritize areas for process improvements.
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