R&D Engineer

Job Description

• Primary focus of this position is to assist R&D engineer medical device process development and testing.
• This would include developing, optimizing, and validating processes for building a medical device; building units for engineering; performing tests, and collecting and analyzing data.
• While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment.
• The employee frequently is required to verbally communicate with other associates.
• The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Essential / Key Job Responsibilities

• Product Builds: Assist, coordinate, track and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing, and commercial sales.
• Sets up and operates manufacturing equipment.
• Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development.
• Assists in conceptual input to the design of fixtures, tooling, and equipment, as well as assists with recommendation, specification, and procurement of capital equipment.
• Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and formal test protocols and reports which comply with GMP and Quality requirements.
• Test Method Development: Review test methods during test method development and assists with test method validations.
• Testing: Ability to perform tests by following instructions from development engineers; collect data and record test results; analyzing test data, organizing and presenting when it is necessary in a reportable format. Assists in the execution of test protocols and procedures. Sets up test equipment for testing to protocols.
• Training: Provides process/test method training to manufacturing and QA personnel.
• Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule.
• Ensure equipment is operating properly. Obtaining quotes for testing and calibration.

Required Qualifications

• Minimum of a Highschool Diploma/GED. Associates of Science degree in science, math or engineering preferred.
• Experience: 1-3 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 1-2 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment. Ability to work with little supervision.
• Experience working in a laboratory and a controlled environment (cleanroom) with knowledge of GMP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for test or pilot processes, is a plus.
• Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel, and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.
• Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis.
• Ability to design (fixture, equipment, and testing). Has general technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g., Solid works).