St. Jude Medical Principal Clinical Engineer in Plano, Texas

Principal Clinical Engineer


Plano, Texas, USA at

Engineering at

Global R&D

160001XLRequisition #

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We are seeking an experienced, high caliber Principal Clinical Engineer to lead clinical engineering team for Neuromodulation products. Support product development efforts by performing clinical engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of specific projects. Clinical Engineering plans and conducts studies, analysis and/or interviews to determine the requirements and constraints on the assigned portion of the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques.

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 accomplishgoals.

Impact this role will have on St. Jude Medical:

  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback

  • Sets goals which align to department plans and manages the execution of goals through coaching and mentoring

  • Maintains a safe and professional work environment

  • Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, evaluate compatibility of system components in clinical workflow scenarios

  • Leads/owns pre-defined tasks within a larger effort such as definition, development, or validation of a system or sub-system, and drives them to on-time, high quality completion

  • Investigates and defines clinical requirements for new devices and system features. Facilitates the transition of these features into new products through clinical review and evaluation

  • Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of new features

  • Simulates or tests aspects of new products or features to evaluate prototypes and validate output as meeting customers’ intended use requirements and proposed product performance and operational characteristics

  • Contributes to the evaluation and validation of a specific subsystem, system or product prior to submission

  • Provides input to the risk management file, including risk brainstorming, Adverse Health Outcome identification, severity and probability assessment

  • Provide input to Clinical Evaluation Reports, including risk-benefit analysis, literature reviews, and overall risk assessment

  • Provides input into the development of clinical validation plans and leads the execution of the clinical validation tests

  • Interacts with project teams and functional groups to conduct feasibility studies, preclinical studies, data development and claims studies, technology assessments, concept studies, or benchmarking studies

  • Understand the scientific, technical, medical, and clinical aspects of SJM Neuromodulation devices and the conditions they aim to treat

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

  • 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

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

  • Four year degree in a technical field, preferably mechanical, chemical, biomedical, electrical or industrial, engineering; materials science, biochemistry, chemistry, or physics or a medical field or equivalent experience

  • Minimum of ten (10) years’ experience in medical device development and/or other highly regulated industry

  • Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects

  • Previous experience leading/managing an R&D or engineering function

  • Experience working in a broader enterprise/cross division business unit model preferred

  • Ability to work in a highly matrixed and geographically diverse business environment

  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

  • Ability to work effectively within a team in a fast-paced changing environment

  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization

  • Multi-tasks, prioritizes and meets deadlines in timely manner

  • Ability to travel approximately 15%, including international

Your preferred qualifications and education:

  • Advanced degree in a technical or medical field is preferred

  • Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred