Apply on Employer Site

MillenniumSoft Inc · 1 month ago

R&D Product Development Engineering Technician - Entry Level (Onsite)

Vernon Hills, IL

Full-time

Onsite

New Grad, Entry Level

0+ years exp

MillenniumSoft Inc is a Medical Devices Company seeking an R&D Product Development Engineering Technician. The primary focus of this role is to assist with R&D EU MDR and manufacturing related testing, including documentation and support for various laboratory activities.

Staffing & Recruiting

No H1B

Responsibilities

Ability to perform testing by following test methods and test protocols from R&D engineers; collecting data and record test results; entering test data into Excel and Minitab, organizing and when needed presenting data and observations to peers and management in a reportable format. Sets up and tears down test equipment for testing per test protocols

Assist in preparation of documentation including test protocols, test reports, work instructions, standard operating procedures, lab notebook studies while complying with GLP, GMP and Quality requirements

Review test methods during test method development and assists with test method validations as a test operator. Assist in reviewing and editing existing test methods as needed

Assist in maintaining test equipment, fixturing, and other lab equipment such as the vacuum system

May provide in-person training on test equipment, test methods, general lab policies and lab safety training to other personnel

May generate purchase orders for general lab supplies, monitor inventory, coordinate shipping materials/receiving in materials including to/from sterilization, ship testing and conditioning for R&D products

Assist in preparation for internal and external audits. Activities may include lab cleanup, labeling product, organizing/optimizing lab casework, confirming lab notebook status and inventory, coordinating cleaning of lab countertops with housekeeping, verifying calibrated equipment location and status, and preparing communication to the R&D team regarding audit timing and rescheduling testing if needed

Comply to budget spend requirements and awareness of the Approved Supplier procedure

Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines

Assist engineers in design and process root cause analysis and support non-conforming product and complaint investigations

Qualification

GMPGLPTest Method DevelopmentMinitabData AnalysisMicrosoft OfficeProblem SolvingCritical ThinkingTeamwork

Required

Minimum of a High School Diploma/GED. Associates of Science degree in science, math or engineering preferred

Experience working in a laboratory with knowledge of GMP, GDP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for testing, 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

Experience with physical testing tools and equipment (hand tools, force and torque gauges, balances, digital and analog gauges, Zwick (or Zwick-like tensile/compression testers like an Instron) is preferred

Experience with laboratory test equipment is a plus

Minimum 0-3 years of industrial experience in R&D or process development, or Associates of Science degree in science, math or engineering

Preferred

Experience in executing test method validations

Ability to analyze test data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis

Ability to optimize test methods utilizing problem solving and critical thinking. Has general technical awareness and amplitude and an ability to read and understand technical specifications and reports (e.g., drawings, flowcharts, operation and maintenance manuals, and directions for use)

Interpret and understand statistical analysis reports