Medical Affairs Research Associate
Hybrid - Onsite in Irvine, CA Tuesday/Thursday and every other Friday
Weekends, Domestic travel will be required up to 80%
Essential Duties & Responsibilities:
- Independently works on in-vivo and bench models for the investigation of cardiac products and how they perform in a simulated clinical use setting.
- Independently identifies data outliers, prepares data for statistical analysis for in-vivo study data
- Assists in in-vivo protocol execution, may develop or be a part of developing new processes/test fixtures or methods for medical device testing
- Interfaces with internal customers within R&D, Medical Safety, and Quality
- May be asked to assist in model development for proper statistical analysis of in-vivo, clinical, and other parametric datasets
- May be asked to assist in the production of mathematical and/or computational modeling of cardiac systems using electromechanical design and controls
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance as well as develop a strong working knowledge of design controls and quality assurance standards of procedure.
- Has a working knowledge of good laboratory practices and operating room procedures
- Willingness to develop an understanding of cardiac electrophysiology procedures and the products used
- Excellent oral and written communication skills are required
Qualification Requirements:
- Experience in working with soft tissue (handling, histology and fixation, including staining and dissection). Previous experience with Bioinstrumentation laboratory equipment.
- Experience in working with large animal (porcine/ovine, etc) and bench top models.
- Strong working knowledge with all of the programs listed: MicroSoft office (specifically Excel and PowerPoint), statistical analysis tools (such as SAS or Minitab, R, SPSS), and working knowledge of Mathematical modeling MatLab software or Prism Job Description
Education & Experience:
- A minimum BS in the Sciences or Engineering or equivalent from an accredited Laboratory Science program, College or University.
- At least 5-8 years of Laboratory experience (Industry and/or Hospital); and/or related medical device development experience and/or training is required. Experience in cardiology, cardiac biophysics and anatomy are preferred