What are the responsibilities and job description for the Product Development Engineering Technician position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description :
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.
Qualifications
Responsibilities :
- Assist, coordinate and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales.
- Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development.
- Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and test protocols which comply with GMP and Quality requirements.
- Review test methods during test method development and assists with test method validations.
- 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.
- Provides process / test method training to manufacturing and QA personnel.
- 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.
- 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.
- Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
Requirements :
Additional Information
Physical Demands :
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
