Senior Clinical Engineer

• Investigates and defines clinical requirements for new product/feature development, and facilitates the translation into new projects through clinical review and evaluation. Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features. 

• Reports significant progress and final findings of projects to management and product development staff in the company. 

• Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications.   

• Identifying potential product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users 

• Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies.   

• Develops and directs preclinical evaluation protocols, data analysis, and reports  

• Contributes to the evaluation and validation of a specific subsystem or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies. 

• Collaborating with other organizations within the company as needed: engineering, regulatory, human factors, quality, marketing, etc 

• Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle. 

• 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. 

• ​ Bachelors Degree in Biomedical Engineering, Mechanical,  Electrical Engineering, a related engineering field, or an equivalent combination of education and work experience

• Minimum of 5 years of relevant work experience in medical product development and/or a graduate degree with relevant project experience.    

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

• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs. 

• Strong analytical, problem solving skills 

• Demonstrated leadership capability in team settings

• experience working in a broader enterprise/cross-division business unit model preferred. 

• 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.  

• Ability to leverage and/or engage others to accomplish projects. 

• Strong verbal and written communication ability  

• Strong organizational and follow-up skills, as well as attention to detail.  

Preferred Qualification and Education 

• Domain knowledge of cardiac rhythm management  (CRM) devices strongly preferred

• 6+ clinical medical device experience or equivalent, ideally with CRM products

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

• Strong analytical, problem solving skills

• Master’s or Doctoral Degree in biomedical, mechanical or electrical engineering, or a biological or physical science or medicine 

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

• Fluent in medical procedure terminology and sound knowledge of cardiac anatomy 

• Medical device experience preferred 

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