Job Title: Clinical Development Engineer

Job Description

A medical device company developing a novel transcatheter therapy for valvular heart disease is seeking a Clinical Development Engineer to support early human use and pivotal clinical studies. This role is based in Irvine, CA.

Responsibilities

• Develop and refine preclinical and clinical procedures.
• Support patient selection and procedural planning using imaging tools such as echo, CT, and fluoroscopy.
• Provide on-site support for clinical cases.
• Assist in regulatory and FDA study planning.
• Create and execute test methods, protocols, and equipment validation.
• Analyze patient outcomes and contribute to design verification.
• Collaborate cross-functionally to improve clinical and technical processes.

Essential Skills

• Strong communication, organizational, and interpersonal skills.
• Ability to work independently in a fast-paced, collaborative environment.
• Proficiency in medical device and clinical development, particularly in cardiovascular areas.
• Experience with Solidworks software.
• Bachelor’s degree in Biomedical, Mechanical, or related engineering field.

Additional Skills & Qualifications

• Experience with imaging software such as 3mensio and TomTec is a plus.
• Familiarity with TMVR (Transcatheter Mitral Valve Replacement) is advantageous.
• Knowledge in new product development, design, research & development, clinical research, clinical studies, and valve design

Job Type & Location

This is a Contract to Hire position based out of Irvine, California.