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.
• 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 todetermine 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.
• 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.
• <10% travel required (domestic and international).
• Fast-paced office environment, requiring significant (75%+) time using computer, mouse and telephone.
• Class III Medical Device, highly regulated environment.