Engineering Technician

Delcath Systems Inc•Queensbury, NY

38d

About The Position

The incumbent will assist in the development of disposable medical devices by fabricating samples, assisting with test method development, and performing required testing. This person will also be responsible for maintaining the metrology lab, performing data entry, basic statistical analysis and preparing the data in clear concise reports. This person will also assist in resolving product issues, supporting continuous improvement initiatives and launch of product line extensions.

Requirements

AS degree in Engineering Sciences or equivalent experience in manufacturing preferred.
Minimum of 3 years relevant experience preferably in the medical device industry
Self-starter, able to work well within the group environment.
Solid organizational skills with the ability to anticipate and adapt to changing situations.
Proficiency in Microsoft Office (Word, Excel)
Must have excellent oral and written communication skills. Must also be able to provide clear/concise documentation and correspondence during project execution.
Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively with employees and outside organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

Nice To Haves

Knowledge of medical device regulations and practices; including ISO requirements and GMP guidelines, FDA regulations and design controls, is a plus.
Capable of developing 3D CAD modeling and drawing dimensioning (SOLIDWORKS Preferred) is a plus.

Responsibilities

Build Samples for process validation (PV) and design verification (DV) testing, clinical request & etc.
Aid in design & fabrication of test fixtures, as required.
Assist in the development of test methods.
Perform test method validations.
Perform a wide variety of laboratory tasks and experiments to support the Company’s research and development goals.
Maintain laboratory equipment and inventory levels for laboratory supplies.
Enter data into Statistical Analysis Software, so that engineers can analyze.
Test product per protocols and test/inspection procedures.
Assist engineers with writing validation protocols/reports as required.
Performs purchasing of production and facilities supplies as required.
Support preventive maintenance activities as required.
Troubleshoot production equipment