Sr. Clinical Specialist

JOB TYPE: Full Time, Employee JOB CATEGORY: Medical/Health CITY: Redmond STATE: WAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Sr. Clinical Specialist Position Description Provide clinical expertise in support of the development, design, manufacture and clinical application of a product.  Perform clinical activities per Standard Operating Procedure.  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 1. Provide input to project plan and statement of need, describing user needs, characteristics, and typical use/application of product; develop customer product performance needs and usability goals. 2. Participate in system hazard analysis; review hazard severity and define mitigations; develop operator error hazard analysis. 3. Determine whether product requirements specification and user interface design document adequately reflect user needs and goals. 4. Plan, facilitate and conduct the design validation process, to include documenting clinical findings, participating in evaluations of product labels, design reviews, and evaluations as necessary. 5. Plan and facilitate creation of operating instruction manual/label, in-service video and other user instructional or clinically oriented literature; evaluate accuracy and adequacy. 6. Prepare documents for 510(k) submission, such as Certification of Summary of Adverse Safety and Effectiveness and operating instruction draft. 7. Plan, develop and conduct investigational studies (IDE’s) as required, in accordance with FDA regulations. 8. Plan and conduct post market surveillance; collect and audit clinical data, interpret results and prepare reports to communicate findings. 9. Assist with data collection for specific research activities. 10. Develop customer, sales and service training materials and provide training as necessary, in collaboration with Product Manager and Clinical Marketing. 11. May prepare and negotiate contracts with clinical sites. 12. May provide guidance to Clinical Specialist. 13. Provide support to product investigations and customer support issues. 14. Perform other related duties as assigned. Basic Qualifications  Bachelor’s degree in Nursing and 6 years' critical care and/or emergency nursing experience.    AHA ACLS provider status required and maintained.    Current RN license.    Equivalent combination of education and experience is acceptable. Desired/Preferred Qualifications 1. Excellent verbal and written communication skills. 2. Prior technical/clinical writing and teaching experience. 3. Proficiency in PC application particularly word processing. 4. Excellent organizational, interpersonal, negotiation and analytical skills. 5. Demonstrated skills in most critical care monitoring techniques, and in project/program management. Physical Job Requirements Fast-paced office environment. Requires significant use of computer keyboard, mouse, and monitor. May lift up to 20 pounds. May require minimal travel. Visit and apply online at www.medtronic.com, requisition #: 60779   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/careers   Click here to see other Medtronic opportunities  Email this Job to a Friend