Tech 2, Product Development Engineering

• Testing: Ability to perform tests by following test protocols from R&D engineers; collect data and record test results; analyzing test data, organizing, and presenting to peers and management when it is necessary in a reportable format. Assists in the execution of test protocols and procedures. Sets up and tears down test equipment for testing to protocols.
• 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. Assist in creating or writing test methods as needed.
• Test Equipment and Fixturing: Assist, coordinate, procure and/or design test equipment and fixturing to facilitate test method development and test method validation testing.
• Training: May provide in-person training on test equipment, test methods, general lab policies and lab safety training to other personnel.
• Equipment: Oversee and document equipment preventative maintenance and repairs on equipment and systems per schedule. Ensure equipment is operating properly. Obtaining quotes for calibration and possible equipment qualifications.
• Materials/Inventory: Generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking including monitoring material and test inventory, shipping materials/receiving materials including to/from sterilization, ship testing and conditioning for R&D products, and where applicable, preparing commercial invoices and liaising with internal Customs specialists.
• Mentoring/coaching: Peer-peer coaching other technicians on R&D based tasks and responsibilities. Oversee activities of entry level technicians in conjunction with their R&D/Lab supervisor.
• Fiscal: Contribute to monthly expense list documenting EU MDR expenses.

Requirements:

• Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Assist in design and process root cause analysis and support non-conforming product and complaint investigations.
• Minimum of a Highschool Diploma/GED.
• Associates of Science degree in science, math or engineering preferred.
• Minimum 5-8 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 4 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment.
• Ability to work without supervision.
• 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.
• Experience in executing validations.
• 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.
• Exposure to statistical analysis and experimental design helpful.
• Experience with physical testing tools and equipment (hand tools, force and torque gauges, balances, digital and analog gauges, Instron (or Instron-like tensile/compression testers) is preferred.
• Any experience with laboratory equipment is a plus.
• Associate degree or higher in science, math or engineering preferred.
• Ability to interrupt test methods and validations, design and/or optimize (fixture, equipment, and testing).
• Has general technical awareness and amplitude and an ability to read and understand technical specifications and reports (e.g., drawings, flowcharts, equipment directions for use).
• Interpret and understand statistical analysis reports.
• Minimum of a Highschool Diploma/GED. Associates of Science degree in science, math or engineering preferred.
• Experience: Minimum 5-8 years of industrial experience in R&D or process development, or associate degree in science, math or engineering with 4 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment.