Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
Key Responsibilities:
•Ensure successful product lifecycle management, from early human use through commercial submission
•Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
•Provide scientific rationale for product attributes and pre-clinical test results
•Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel
• Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
• Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.
• Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
• Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
• Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
•Analyze data to support clinical trial safety investigations and new product development
•Other duties as assigned by leadership
Education and Experience:
Bachelor's Degree in biology or lifesciences field, Years years experience Class II and III medical device technologies and/or clinical studies background Required
Bachelor's Degree in engineering Preferred
Additional Skills:
• Proven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with pre-clinical testing protocols, hospital environments and sterile techniques
• Data analysis skills, with understanding of statistical analysis techniques
• Good communication and organizational skills
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Demonstrated problem-solving and critical thinking skills
• Thorough, conscientious and results oriented working style
• Team oriented
• Ability to work in a dynamic work environment
• Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
• Adhere to all company rules and requirements (, pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred
EEO:
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