Product Development Engineering Technician

Job Description

The primary focus of this position is to complete R&D medical device testing. This would include performing tests and collecting and analyzing data.

• Testing:
• Functional testing, i.e. Leak, tensile and burst testing of medical devices.
• 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.
• Documentation:
• Aid in the preparation, development, and implementation of documentation including work instructions, standard operating procedures, technical reports, change requests and formal test protocols and reports which comply with GMP and Quality requirements.
• Equipment:
• Ensure equipment is operating properly.
• Test Method Development:
• Review test methods during test method development and assist with test method validations.
• Process Development:
• Support tooling and equipment development. Assist in input to the design of fixtures, tooling and equipment, as well as assist with recommendation, specification and procurement of capital equipment.
• Training:
• Provide process/test method training to other R&D personnel as needed.

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 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, and Excel ) and ability to enter data in 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.

Physical Demands

• 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.

Work Environment

• While performing the duties of this job, the employee may be in an open cubicle environment.
• Candidate must be able to work in a team-oriented, fast-paced environment.