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

R&D Product Development Engineering Technician - Entry Level (Onsite) Location: Vernon Hills, IL Duration: 10 Months Total Hours/week: 40 Shift: 1st Shift Client: Medical Devices Company Job Category: Engineering/Technical Level of Experience: Entry Level Employment Type: Contract on W2 (U.S. Citizen, Green Card, EAD, OPT, CPT holders only) Job Description Primary focus of this position is to assist R&D EU MDR and Manufacturing related testing, and associated test adjacent tasks. Receiving in, staging, labeling, tracking and prepping test product; trialing test methods to confirm and optimize test steps prior to validation. Drafting portions of Test Protocols, Test Reports, SOPs, and Work Instructions; performing discovery and feasibility testing and documenting testing in lab notebooks; collecting and entering data; performing independent reviewer activities; supporting testing at outside laboratories; renewing confidentiality agreements; supporting calibration activities; conducting in-person lab safety training to new hires and new lab associates; conducting bi‑monthly lab inspections; monitoring the Deionize Water system; coordinating disposal of medical products and sharps with Environmental Health & Safety. Testing: Perform testing by following test methods and protocols from R&D engineers; collect data and record test results; enter test data into Excel and Minitab; organize and present data and observations to peers and management in a reportable format; set up and tear down test equipment per test protocols. Documentation: Assist in preparation of documentation including test protocols, test reports, work instructions, standard operating procedures, and lab notebook studies while complying with GLP, GMP, and Quality requirements. Test Method Development: Review test methods during development and assist with test method validations as a test operator; assist in reviewing and editing existing test methods as needed. Test Equipment and Fixturing: Assist in maintaining test equipment, fixturing, and other lab equipment such as the vacuum system. Training: Provide in‑person training on test equipment, test methods, general lab policies, and lab safety training to other personnel. Materials/Inventory: Generate purchase orders for general lab supplies; monitor inventory; coordinate shipping materials and receiving in materials, including to/from sterilization and ship testing and conditioning for R&D products. Audit Support: Assist in preparation for internal and external audits, including lab cleanup, labeling product, organizing and optimizing lab casework, confirming lab notebook status and inventory, coordinating cleaning of lab countertops with housekeeping, verifying calibrated equipment location and status, and communicating audit timing to the R&D team. Fiscal: Comply with 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. Required Qualifications Minimum of a High School Diploma/GED; Associate of Science degree in science, math or engineering preferred. Experience working in a laboratory with knowledge of GMP, GDP and GLP; 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, 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 such as an Instron) is preferred. Experience with laboratory test equipment is a plus. Preferred Qualifications Experience in executing test method validations. Ability to analyze test data and recommend actions; practical and technical knowledge of root cause and statistical methods and analysis. Ability to optimize test methods utilizing problem solving and critical thinking; general technical awareness and ability to read and understand technical specifications and reports. Interpret and understand statistical analysis reports. Education and/or Experience Minimum of a High School Diploma/GED; Associate of Science degree in science, math or engineering preferred. 0‑3 years of industrial experience in R&D or process development, or an Associate of Science degree in science, math or engineering. Preferred: 1‑2 years related experience, preferably in a medical device or other regulated FDA/QSR and ISO environment. Physical Demands While performing the duties of this job, the employee is required to regularly stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee is frequently required to verbally communicate observations and physically demonstrate test designs discovered during testing to engineers and other test operators. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch when receiving in, labeling, staging, and storing test product. 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. Client is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a simulated use or an offsite usability study. #J-18808-Ljbffr MillenniumSoft Inc