Product Development Engineering Technician

pay range -$25-30/hr

• Primary focus of this position is to assist R&D EU MDR and Manufacturing related testing, and associated test adjacent tasks.
• This would include receiving in, staging, labeling, tracking and prepping test product, trialing test methods to confirm and optimize test steps prior to validation.
• Other tasks may include 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 to the lab associates, conducting bi-monthly lab inspections, monitoring the Deionize Water system, and coordinating disposal of medical products and sharps with Environmental Health & Safety.
• Testing:
  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.
• Documentation:
  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.
• Test Method Development:
  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.
• Test Equipment and Fixturing:
  Assist in maintaining test equipment, fixturing, and other lab equipment such as the vacuum system.
• Training:
  May provide in-person training on test equipment, test methods, general lab policies and lab safety training to other personnel.
• Materials/Inventory:
  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.
• Audit Support:
  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.
• Fiscal:
  Comply to budget spend requirements and awareness of the Approved Supplier procedure.

• Testing:
  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.
• Documentation:
  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.
• Test Method Development:
  Review test…