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Stryker.

Physio-Control - Principal Clinical Specialist - Redmond WA

Stryker. - Redmond, WA

Physio-Control - Principal Clinical Specialist - Redmond WA

in

Redmond

Washington

Requisition ID

25691BR

Job Title

Physio-Control - Principal Clinical Specialist - Redmond WA

Group

MedSurg and Neurotech

Division

Medical

Business Function

Clinical Affairs

Country

United States

State/Province

WA

City

Redmond

Employment Category

Full Time

Percent Travel Required

Up to 10%

Shift

1st

About Stryker

Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All 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.

Job Description / Information

GENERAL SUMMARY:

Provide clinical expertise in support of the design, development, manufacture and clinical application of a product. Develop and implement design validation best practices. Provide clinical support and advocate for the needs of the user and patient to ensure promotion of safe and effective products. Serve as an expert to the Clinical Affairs team, directly assist with data analysis and reporting for specific investigations related to assigned project or study and act as a principle-level consultant to other functional groups regarding clinical issues.

MAJOR DUTIES/RESPONSIBILITIES:

• Own quality system processes and leads process improvement projects at the functional level.

• Demonstrate proficiency to corporate Quality System procedures and Technical Standards to ensure compliance with required class II and III medical device regulations.

• Develop User Needs Document as a basis for Design Validation.

• Provide input to, project plans, pre-Submission 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 specifications 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 and key opinion leader 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 Complaint investigations and Corrective and Preventative Action activities.

• Plan and facilitate creation of operating instructions and evaluate accuracy and adequacy.

• Prepare clinical content for documents to support regulatory requirements.

• Plan and develop protocols for minimal risk Clinical Studies; work as clinical liaison between Institutional Review Board (IRB) and internal Regulatory staff to execute procedures and conduct clinical studies.

• Plan and conduct post market surveillance; collect and audit clinical data, interpret results and prepare reports to communicate findings.

• 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.

Minimum Qualifications

BASIC QUALIFICATIONS:

Bachelor’s degree in Nursing or related discipline

8 years nursing or equivalent experience

5 years’ critical care and/or emergency experience.

Equivalent combination of education and experience is acceptable.

AHA ACLS current or prior provider status required and recommended to be maintained.

Minimum of 2 years in a clinical function within a medical technology, biotechnology, pharmaceutical or related corporate experience.

Current RN license.

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.

• 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).

• Proficiency in PC applications, including Word, Excel.

WORKING CONDITIONS:

• Fast-paced office environment, requiring significant (75% ) time using computer, mouse and telephone.

• Class III Medical Device, highly regulated environment.

All 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

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Physio-Control - Principal Clinical Specialist - Redmond WA Stryker. - Redmond, WA, United States

   

Location: Redmond, WA

Company Profile:
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.