Physio-Control - Sr Clinical Specialist - Redmond in Redmond, WA at Stryker Corporation

Date Posted: 9/19/2018

Job Snapshot

Job Description

The Lead Analyst, Clinical Research 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 at Stryker's Physio-Control location in Redmond, WA.  Will further provide clinical support and advocate for the needs of the user and patient to ensure promotion of safe and effective products.

Major Duties/Responsibilities:             

  • 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.
  • Plan, develop and conduct the design validation process, including usability protocols to demonstrate understanding of labeling or intuitiveness of product design.
  • 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.
  • 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.
  • In collaboration with Product Managers and Clinical Marketing, assist in the development of customer, sales and service training materials.
  • Perform other related duties as assigned.

Basic Qualifications:

  • Bachelor’s degree in Nursing or related field or related experience in an advanced practice environment (such as critical care, critical care transport, emergency room, etc.) or military medical training.
  • 5 years critical care and/or emergency experience.
  • AHA ACLS current or prior provider status required and recommended to be maintained. 
  • Current RN license; EMT Paramedic or Flight Nurse. 

Preferred/Desired Qualifications:

  • 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.
  • Nursing experience in Cardiology (general or any sub-specialty).
  • Experience in clinical research nursing.
  • Nursing experience in outpatient device education or cardiac rehabilitation.
  • Experience in ambulatory care nursing (ex: telehealth nursing certification).

Working Conditions:

  • Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone.
  • Class III Medical Device, highly regulated environment.

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.


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