Sr Specialist, Clinical Development

Overview

Aortic stenosis impacts millions of people globally, yet it often remains under‑diagnosed and under‑treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life‑changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.

It’s our driving force to help patients live longer and healthier lives.

• Ensure product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
• Ensure successful product lifecycle management for multiple complex projects, including: develop and implement pre‑clinical test strategy and provide guidance to team members on execution strategy.
• Design, prepare and conduct first‑in‑man product evaluations, including case support for proper product use; create Clinical Investigator Brochure.
• Develop clinical trial strategy and provide scientific rationale for product attributes and pre‑clinical test results to regional clinical teams necessary to obtain site and country approvals.
• Provide product expertise for new product introduction training for clinical and site personnel.
• Design, develop, conduct, and assess results of post‑market evaluations.
• Develop, review, and update clinical design control documents, including advice and guidance to product development team on technical summaries, clinical risk assessments, validation protocols and reports, and application of FMEAs for technical and clinical documentation.
• Ensure 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 trial managers to gather field device performance feedback, and 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.

Other duties as assigned by leadership.

• Required:
  
  Bachelor’s Degree in biology or life sciences field; 5 years experience with Class II and III medical device technologies and/or clinical studies background.
• Required:
  
  Bachelor’s Degree in engineering.
• Travel up to 50% nationwide.

• Proven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet;
  Adobe, and ability to operate general office machinery.
• Experience with pre‑clinical testing protocols, hospital environments and sterile 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, 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, GLP and GCP.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules). Take adequate control measures in preventing injuries to themselves and others as well as to protection of environment and prevention of pollution under their span of influence/control.

We offer competitive salaries, performance‑based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is…