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For your reference, we have included the original job posting below.
Sr Clinical Specialist Job
Job Number:
25495910
Company Name:
Medtronic
Job Location:
Redmond, WA US
Job Category:
Healthcare & Medical
Sr Clinical Specialist Job
Sr Clinical Specialist
Requisition 72670 Category Clinical Studies Business Physio-Control Division Physio-Control Location USA-WA-Redmond Relocation Relocation eligibility to be determined Job Type Full Time - Regular Exempt/Non-Exempt Exempt Shift First Travel Percentage less than 10% Experience Required 6 years Education Required Bachelor of Nursing Degree
Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description
GENERAL SUMMARY Provide clinical expertise in support of the design, development, manufacture and clinical application of Advanced Life Support (ALS) and Basic Life Support (BLS) products and accessories. Perform clinical activities per Quality System Work Instructions and Technical Standards. Assist with data analysis and reporting for specific investigations related to assigned project or study. Act as a consultant to other functional groups regarding clinical issues.
Position Responsibilities
MAJOR DUTIES/RESPONSIBILITIES Provide input to user needs specifications, project plans, pre-IDE and 510(k) applications by describing user needs, characteristics, intended use and clinical application of products; develop customer product performance needs and usability goals. Participate in system hazard analysis; review hazard severity and define mitigations; develop operator error hazard analysis. Determine whether product requirements specification and user interface design documents adequately reflect user needs and usability goals. Plan, develop and conduct the design validation process, including usability protocols to demonstrate understanding of labeling or intuitiveness of product design, recruitment of external users for usability testing (formative and summative simulated use testing) of product labeling and user interface, evaluation of product performance, documentation of findings, and participation in design reviews and other evaluations as necessary. Plan and facilitate creation of operating instructions (manuals, labeling, quick reference labeling, unpacking instructions, in-service video and other user instructional or clinically-oriented literature) and evaluate accuracy and adequacy. Prepare documents for 510(k) submission, such as Certification of Summary of Adverse Safety and Effectiveness operating instruction draft and validation evidence for claims. Plan, develop and conduct investigational studies (IDE's) as required, in accordance with FDA regulations. Plan and conduct post market surveillance; collect and audit clinical data, interpret results and prepare reports to communicate findings. Review product related complaints related to potential adverse events or device malfunctions to determine whether or not the device use contributed to harm. Provide input to and participate in post production Corrective and Preventative Action activities. Assist with data collection for specific research activities. In collaboration with Product Manager and Clinical Marketing, develop customer, sales and service training materials and provide training as necessary. May prepare and negotiate contracts with clinical sites. Provide support to marketing and engineering for customer issues. Perform other related duties as assigned.
Basic Qualifications
BASIC QUALIFICATIONS Bachelor's degree in Nursing 6+ years of critical care and/or emergency nursing experience. AHA ACLS current or prior provider status required and recommended to be maintained. Current RN license. Demonstrated skills in most critical care monitoring techniques; ECG rhythm interpretation skills required.
Desired/Preferred Qualifications
PREFERRED/DESIRED QUALIFICATIONS Excellent verbal and written communication skills. Prior technical/clinical writing and teaching experience. Prior medical device product development, including embedded software experience. Prior software/web application development. Proficiency in PC applications, including Word, Excel and Adobe Acrobat. Database and Visio experience a plus. Excellent organizational, interpersonal, negotiation and analytical skills. Project/program management experience, MS project experience a plus.
Physical Job Requirements
Working Conditions Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone Some travel may be required Mission-oriented culture, energized by the knowledge that our products save lives every day, and our work here has a very material impact on the delivery of healthcare around the world. High volume communication role Class III Medical Device, highly regulated environment
