Senior Clinical Engineer

• Investigates and defines clinicalrequirements for new product/featuredevelopment, andfacilitates the translationinto new projects through clinical review and evaluation.Works with field and medical personnel to define the benchmarks for evaluating the clinical performance ofthese 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 projectas necessaryto conduct feasibility studies,usability and human factors analyses,technology assessments, concept studies,benchmarking studies, orsubmissionstudies 

• 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 relevantwork experience in medical product development and/or a graduate degree with relevant project experience.  

• Demonstrated ability to apply understanding of clinical application to issuesin order tobring 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

• experienceworking 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 asanindividual contributor in a fast-paced,changing environment.

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

• Strong verbal andwritten communication ability

• Strong organizationaland follow-up skills, as well asattention to detail

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