Job Description

Staff Clinical Specialist

Who we want

* Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
* Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
* Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
* User-focused creators. People who imagine with the user in mind, developing technology that helps change patients lives.

What you will do

As a Staff Clinical Specialist, you will 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. You will also provide clinical support and advocate for the needs of the user and patient to ensure promotion of safe and effective products. Responsibilities include:

* 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) and PMA 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.
* Develop User Needs Document as a basis for Design Validation.
* Determine whether product requirements specification and user interface design and design documents adequately reflect user needs and usability goals.
* Interface with customers for the development of use scenarios and user needs; establish customer contacts for clinical use questions and as usability contacts.
* Review product related complaints related to potential adverse events or device malfunctions to determine whether or not the device use contributed to harm.
* Analyze data reports and summarize results pertinent to product design and usability.
* Provide input to and participate in post-production Corrective and Preventative Action activities.
* Plan and facilitate creation of operating instructions (manuals, labeling, quick reference labeling, operator installation/getting started instructions, in-service video and other user instructional or clinically-oriented literature) and evaluate accuracy and adequacy.
* Prepare documents for 510(k) and PMA submission, such as Certification of Summary of Adverse Safety and Effectiveness; Prepare Clinical Evaluation Report for Technical Documentation File to support CE Mark and other Regulatory documents as required.
* Plan and facilitate creation of operating instructions and evaluate accuracy and adequacy.
* 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 (IDEs) as required, in accordance with FDA regulations.
* In collaboration with Product Managers and Clinical Marketing, assist in the development of customer, sales and service training materials.
* Provide support to marketing and engineering for customer issues.
* Perform other related duties as assigned.

What you need

* Bachelors degree in Nursing or related field, or related experience in an advanced practice environment such as critical care, critical care transport, emergency room, flight nurse or military medical training.
* 3+ years of critical care and/or emergency experience
* AHA ACLS current or prior provider status required and recommended to be maintained
* Current RN license; or Paramedic certification

You might also have

* Excellent organizational, interpersonal, negotiation and analytical skills.
* Excellent verbal communication skills.
* Demonstrated skills in critical care monitoring techniques; ECG rhythm interpretation 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.
* Prior medical device product development.
* Proficiency in PC applications, including Word, Excel.
* Cardiology experience such as cardiac arrest response, code blue response, rapid response/medical emergency team, ACLS trainer, cardiac surgery, or interventional radiology/catheterization lab
* Experience with AED, defibrillation, synchronized cardioversion and external pacing use
* Experience in clinical research

Working Conditions

* Up to 25% travel required
* Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone
* Testing days require 8-12 hours standing and interacting with equipment and others
* Class III medical device, highly regulated environment