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Senior Engineer, Clinical Development

3 months ago

Irvine, United States ReValve Solutions Full time

Company Description

ReValve Solutions is a medical device company based in Irvine, CA that delivers a first-of-its-kind, lifelong solution for one of the most common diseases in the world: valvular heart disease. Our Palmetto System is a non-invasive valve replacement device which mimics the contraction of the heart to improve and lengthen the lives of millions of patients. We are currently an investigational device only.

Role Description

This is a full-time, on-site role for a Senior Engineer, Clinical Development. The Clinical Development Engineer will be responsible for developing the ReValve Solutions therapy for successful patient outcomes through an Early Feasibility Study and Pivotal Study. This will include patient selection, procedural development, patient modeling, supporting clinical cases, and tracking patient outcomes through rigorous analysis. This role will be based in Irvine, CA.

Qualifications

  • Execute on all development, testing and preparedness of preclinical and clinical procedures to reach development milestones
  • Proceduralize all patient selection guidance and execution (echo, CT, Fluoroscopy). Familiarity with 3mensio is a requirement.
  • Provide close collaboration with R&D team to ensure seamless design intent into the clinic and back to R&D for design optimization
  • Develop patient selection criteria and assist with patient screening process for first-in-human and EFS studies
  • Provide support for pre-clinical and clinical cases, on-site case support as needed.
  • Assist in FDA roadmap efforts, to include, pre-clinical and clinical studies
  • Develop various clinical and regulatory programs to enable a series of Clinical Cases
  • Assist developing and executing protocols for evaluation of the technology design, processes, various test methods, equipment validation and manufacturing processes
  • Assist with conducting design verifications for new product development designs and IQ/OQ with software validations to support new equipment
  • Be current on new industry trends and technologies
  • Evaluate internal systems and make recommendations to improve effectiveness
  • Ensure adherence to best practice (as regard to intellectual properties) and regulatory requirements. Ensuring company's technological processes comply with all requirements, laws, and regulations
  • Maintain and build trusted relationships with key customers. clients, partners, and stakeholders

What we look for

  • Strong communication and interpersonal skills
  • Attention to detail and strong organizational skills
  • Independent and passionate with strong work-ethic
  • Excellent interpersonal skills with proven track record of strong team collaboration
  • Ability to multitask and prioritize tasks
  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field is preferred

Benefits and Pay

  • We offer medical, dental, vision, life, and 401(k) package. Your position within the salary range and bonus will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications.