Sr. Clinical Specialist
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. Clinical Specialist for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
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.
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.
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.
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