Engineering Technician

POSITION SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• 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

The Technician has no supervisory responsibilities. 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• AS degree in Engineering Sciences or equivalent experience in manufacturing preferred.


• Minimum of 3 years relevant experience preferably in the medical device industry


• Knowledge of medical device regulations and practices; including ISO requirements and GMP guidelines, FDA regulations and design controls, is a plus.


• 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)


• Capable of developing 3D CAD modeling and drawing dimensioning (SOLIDWORKS Preferred) is a plus.


• Must have excellent oral and written communication skills. Must also be able to provide clear/concise documentation and correspondence during project execution.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

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.

PHYSICAL DEMANDS 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.