Staff Clinical Specialist

COVID-19 vaccination requirements
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.
Why join Stryker? We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.

We are currently seeking a Staff Clinical Specialist to join our Medical Division to be based in Redmond, WA.

Who we want

• 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.
  
• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  

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.

• 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
  
• 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.
  
• Provide input in the 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) 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 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.
  
• Provide support to marketing and engineering for customer issues.
  
• Perform other related duties as assigned.
  

What you need

• A minimum of a Bachelor's Degree required.
  
• A 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 required.
  
• A minimum of 5 years of experience required; including within critical care and/or emergency experience.
  
• AHA/ACLS current or prior provider status recommended to be maintained.
  
• Current RN license or Paramedic certification preferred.
  

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.
  

Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com