Engineering Technician

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens, GC Holders)

Position: Engineering Technician

Location: Tempe, AZ

Duration: 12-Month contract

Total Hours/week: 40.00

Primary focus of this position is to assist R&D engineer medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; building units for engineering; performing tests, and collecting and analyzing data.

• Product Builds:
  Assist, coordinate, track and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales. Set up and operate manufacturing equipment.
• Process Development:
  Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development. Assist in conceptual input to the design of fixtures, tooling and equipment, as well as assist with recommendation, specification and procurement of capital equipment.
• 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.
• Testing:
  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. Assist in the execution of test protocols and procedures. Sets up test equipment for testing to protocols.
• Training:
  Provide process/test method training to manufacturing and QA personnel.
• Equipment:
  Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule. Ensure equipment is operating properly. Obtain quotes for testing and calibration.
• Materials/Inventory:
  Generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials/receiving materials, preparing commercial invoices and liaising with internal Customs specialists.
• Mentoring/coaching:
  Peer-peer coaching other technicians on R&D based tasks and responsibilities.
• Other Responsibilities may include, however are not limited to:
  Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

• 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 knowledge of root cause and statistical methods and analysis.
• Ability to work and manage priorities with little supervision.
• Strong written and verbal communications skills; able to convey project status and elevate issues efficiently and clearly.

• Experience working in a laboratory or a controlled environment (cleanroom) with knowledge of GMP and GLP.
• Experience with building or testing components and products
• Ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment.
• Familiar with process validation (IQ, OQ and PQ); ability to assist in executing validation.
• Experience in medical device or other regulated FDA/QRS and ISO environment
• Ability to design (fixture, equipment, and testing). General technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. Solidworks).

Education:

High diploma required;
Associates degree or higher in science, math or engineering preferred.

• 2 years of relevant work experience such as experience as a laboratory technician or manufacturing operator.
• Associates degree in science, math or engineering with 1 year relevant work experience.

While performing the…