Company: Katalyst Healthcares & Life Sciences
Posted on: August 3, 2022
Key Job Responsibilities:
Primary focus of this position is to assist R&D engineer
medical device process testing and development. This would include
performing tests, and collecting and analyzing data, developing,
optimizing, and validating processes for building a medical device,
building units for engineering.
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.
Sets up and operates manufacturing equipment.
Process Development: Assist in new process development for new or
existing medical devices and processes, supporting tooling and
Assists in conceptual input to the design of fixtures, tooling and
equipment, as well as assists 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
Test Method Development: Review test methods during test method
development and assists with test method validations.
Testing: Ability to 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. Assists in the execution of test protocols
and procedures. Sets up test equipment for testing to
Training: Provides 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. Obtaining 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
High School Diploma/GED required; Associates of Science degree in
science, math or engineering preferred.
experience in R&D or related process development experience;
medical device or other regulated environment highly preferred.
Experience working in a development testing lab with knowledge of
good documentation practices.
Ability to assist in executing testing protocols.
and ability to enter data in Microsoft Project and / or Minitab for
Ability to assist in design. General technical awareness and
ability to read and understand drawings.
Keywords: Katalyst Healthcares & Life Sciences, Tempe , Lab Technician, Professions , Tempe, Arizona
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