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R&d Engineer

R&d Engineer

ActalentIrvine, CA, US
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Clinical Development Engineer

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.

    Pay and Benefits

    The pay range for this position is $67.00 - $97.00 / hr.

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off / Leave (PTO, Vacation or Sick Leave)

    • Workplace Type

    This is a fully onsite position in Irvine,CA.

    Application Deadline

    This position is anticipated to close on Sep 16, 2025.

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    Rd • Irvine, CA, US