Medical Affairs Research Associate

Company: Softworld Inc
Location: Foothill Ranch
Posted on: February 4, 2025

Job Description:

Job Title: Medical Affairs Research Associate

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Job Location: Irvine California 92618 (40% travel)

Onsite Requirements:


Top Skill #1 - Someone with proven track record of working within Cardiology and working in the cardiac space.
Top Skill #2 - Experience in working with soft tissue (handling, histology and fixation, including staining and dissection).
Top Skill #3 - Previous experience with Bioinstrumentation laboratory equipment and experience in working with large animal (porcine/ovine, etc) and bench top models.


Job Description:

Summary:

Essential Duties and Responsibilities include the following. Other duties may
be assigned.


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:


To perform this job successfully, an individual
must be able to perform each essential duty well.
The requirements listed below are representative of the knowledge, skill, and/or ability required: 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
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.

Education and/or 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.

Other Skills and Abilities:


Computer skills is strongly required.
Good written and oral English communication skills essential.
Weekends, Domestic travel will be required at least 40%.


** 3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply. **

Keywords: Softworld Inc, Costa Mesa , Medical Affairs Research Associate, Healthcare , Foothill Ranch, California