Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Sr. Clinical Specialist at a prestigious Fortune 500 company working in Redmond, WA.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "Submit Resume" button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the "Submit Resume" button included within.
Job Title: Sr. Clinical Specialist
Position 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. Support usability and clinical evaluations and design validation activities.
Demonstrate proficiency to corporate Quality System procedures and Technical Standards to ensure compliance with required class III medical device regulations.
Provide input to, project plans, pre-IDE and 510(k) applications by, describing user needs, user characteristics, intended use and clinical application of products; develop operator product performance needs and usability goals; advocate the safety of devices for the operator and the patient.
Participate in the development of safety risk analysis; identify system hazards, hazard severity and develop and validate mitigations; develop operator error hazard analysis.
Determine whether product requirements specification and user interface design and 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.
Analyze data reports and summarize results pertinent to product design and usability.
Plan and develop protocols for minimal risk Clinical Studies; work as clinical liaison between Institutional Review Board and internal Regulatory staff to execute procedures and conduct clinical study.
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.
Assist with data collection for specific research activities.
Basic Qualifications :
Current or Former Nursing license or Paramedic license
5+ years critical care, emergency care, critical transport or equivalent experience.
AHA ACLS and/or PALS current or prior certification, recommended to be maintained.
Equivalent combination of education and experience is acceptable.
Demonstrated skills in critical care monitoring techniques; ECG rhythm interpretation skills.
Preferred Qualifications :
ACLS, PALS, and/or Code response trainer or instructor experience, preferred
Experience using simulators and running scenarios for user testing, preferred
Prior medical device product development, including embedded software experience, preferred.
Excellent organizational, interpersonal, negotiation and analytical skills.
Excellent verbal communication skills.
Ability to compose and edit technical and clinical documents for regulatory submissions.
Ability to collaborate with a variety of functional areas, from Marketing to Engineering.
Proficiency in PC applications, including Word, Excel and Adobe Acrobat. Database and Visio experience a plus.
Project/program management experience, MS project experience a plus.
Working Conditions :
25% travel required
Fast-paced office environment, requiring significant time using computer, mouse and telephone
Usability and clinical testing may require standing and interacting for 8-12 hours
Class III Medical Device, highly regulated environment
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com at http://www.kellyservices.com/ .
Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
Why Kelly **** ?
With Kelly, you'll have access to some of the world's highest regarded scientific organizations-providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today.
About Kelly ****
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm