Senior Clinical Specialist (Hybrid) - Washington, Redmond 11811 Willows Rd Ne

Work Flexibility: Hybrid

Stryker Medical is hiring a Senior Clinical Specialist (Hybrid) in Redmond, WA! In this role, 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.

Work Flexibility: Hybrid. This role requires reasonable proximity to our facility in Redmond, WA. You should be comfortable working 3-days onsite.

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.

What you will do

• 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

Required:

• 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.

• 2+ years of experience required, including within critical care and/or emergency experience.

Preferred:

• Current RN license or Paramedic certification preferred.

• AHA/ACLS current or prior provider status recommended to be maintained.

• 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.

• $75,300.00 - $156,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

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.