Clinical Research Engineer

3 weeks ago

Santa Clarita, United States huMannity Medtec Full time

At huMannity Medtec we will give you the opportunity to change the lives of millions who are suffering – it’s what we do We have been at the bleeding edge of medical technology innovation for over 35 years, and we are looking for smart, motivated, and diverse people to help us advance our mission in a truly meaningful way. We will give you what you need to succeed, thrive, and progress, including a tremendous workplace culture featuring a collaborative spirit, fun-loving team, and experienced leadership.


We truly understand the need for balance and, among other things and offer a 9/80 schedule with every other Friday off. That’s 26 long weekends a year


Essential Duties and Responsibilities: Responsibilities include the planning, conducting, and interpretation of medical device pre-clinical/clinical research and Human Factors activities. This position plays a key role in the development and execution of pre-clinical, feasibility and first-in human trials intended to support regulatory registration of new indications and new medical devices, as well as physician-initiated and company sponsored, and grant funded clinical trials.



Summary of Job Duties:

  • Handle/manage all duties related to the execution of US/OUS Class 3 Medical Device Clinical Trials in line with GCP, Regulatory and Compliance requirements.
  • Drive study related activities from pre-clinical/clinical protocol design to Human Factors input, data management, study start-up/execution/close-out for one or several studies.
  • Collaborate with SW and Systems Engineering on identifying and classifying issues reported during early research/engineering testing.
  • Collaborate with other cross-functional teams (Quality, R&D, Regulatory, CROs, statisticians)
  • Train field clinical representatives and clinical sites on study protocols and investigational products.
  • Drive investigator meetings, Steering Committees Meetings, Events Adjudication Committees and DSMB meetings.
  • Conduct remote study monitoring and internal study audits.



Skills, Education and Knowledge Requirements:

  • BS or MS degree in Engineering (Biomed, Mechanical, Electrical).
  • 4+ years of experience in Clinical Trials for Class 3 medical devices.
  • Experienced with EDC systems and internal research tools to analyze clinical data.
  • Experienced in maintaining a safe study environment by reporting Serious Adverse Events (SAEs), following organization standards and legal regulations.
  • Experienced in independently writing protocols, reports of findings, publications, and other technical documents.
  • Experienced in planning investigator meetings, Steering Committees Meetings, Events Adjudication Committees and DSMB meetings.
  • Strong knowledge of clinical study guidelines (FDA, ICH and GCP) for Class III medical devices.
  • SoCRA or ACRP Certification preferred.
  • Skilled at designing experiments/studies, data collection and analysis, use of machine learning.


Must be able to travel as required - less than 20%

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