Engineering Technician III

Job Description

Job Description

Summary / Purpose :

Under minimal supervision, the Engineering Technician III is responsible for assisting management in completing projects.  Engineering Technician III will be responsible for trouble shooting processes, proposing corrective action, and implementing approved activities.

The Engineering Technician III will be responsible for developing the necessary plans, schedules, and budgets for each project, engaging in hands-on work associated with the project, and assuring that the corresponding schedule, budgetary constraints, and project goals are met.  The projects and activities associated with this position include developing Preventative Maintenance and Calibration procedures, troubleshooting and / or optimization of existing manufacturing processes, developing new manufacturing processes and / or systems and equipment.

The Engineering Technician III will be responsible for the day-to-day activities associated with these projects and will be responsible for developing and executing the necessary qualification / validation protocols and written reports in the support of the project goals.

Essential Functions :

1)  Must met the requirements of Engineering Technician I and II

2) Work with Managers and other team members, including engineering, RA / QA, Production, and external consultants (if necessary) to develop project goals.

3) Evaluate Engineering procedures to create assessments and propose new changes if required.

4) Oversee proper execution of engineering procedures and documentation.

5) Evaluate manufacturing methods and create manufacturability assessments which incorporate process improvements such as the use of selected materials, equipment, tooling and / or automated systems.

6) Troubleshoot both new and existing manufacturing / packaging processes, propose and implement appropriate action plan.

7) Revise and / or develop new equipment operating, manufacturing procedures.

8) Develop and execute test protocols in support of related product / process qualification / validation activities.

9)  Ability to work independently with minimal supervision.

10)  Ability to coordinate and complete multiple projects.

11)  Perform periotic equipment requalification and process revalidation activities.

12)  Capable of safely operating and maintaining basic manufacturing and shop equipment such as presses, ovens, mixers, scales, drills, drill press, saws, and hand tools as well as basic lab and office equipment.

13)  Familiarity with AC / DC electrical systems and basic operating principles for pneumatic / hydraulic systems.

14)  Capable of maintaining effective and regular interactions with fellow department members and outside contractors / vendors.

15)  Required to be present in the work place during scheduled work hours.

Marginal Functions :

Perform other project engineering related duties.

Participate in other functions as directed.

Physical Demands :

The physical demands and work environment characteristics 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 frequently required to sit at a computer workstation for extended periods of time while typing and using a mouse or other curser controlling device.  The employee is regularly required to stand, walk and use hands to finger, handle or feel. The employee is frequently required to reach with hands or arms, talk and hear. The employee frequently will use either one or both hands to firmly grasp, push and / or pull. The employee will occasionally reach overhead to grasp objects and lift or carry up to 60 pounds. It will be necessary to be around equipment and machinery and work in a laboratory, machines shop, maintenance shop and cleanroom environment.  Normal 20 / 20 vision ability (with corrective lenses, if needed) is required.

Qualifications and Requirements :

To perform this job successfully, an individual must be able to perform each essential function satisfactorily.  The requirements listed below are representative of the knowledge, skills and / or abilities required.

Education :

10 years technical experience or equivalent combination of training and experience are necessary.

Skills :

1)  Strong organizational, interpersonal, problem solving and analytical skills.

2)  Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

3)  Ability to clearly present information in written form including business correspondence, equipment qualifications, test protocols, technical reports, procedures, emails, and information memoranda in English.

4)  Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.

5) Capable of reading and understanding drawings and schematics.

6)  Manual dexterity required.

7)  Ability to function in a controlled environment regulated by FDA GMP's and ISO guidelines.

8)  Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment and be flexible in changing daily workload priorities as directed.

9)  Ability to accurately perform detail-oriented work within a laboratory, machine shop, maintenance shop and cleanroom environment.

10)  Must possess good computer skills and be proficient with MS Office suite and SolidWorks or other CAD programs.  In addition, must be able to work with data processing, programming, systems design and problem analysis.

11)  Ability to take initiative and make decisions for projects.

Mathematical Skills :

Ability to apply mathematical concepts such as fundamentals of plane and solid geometry, and trigonometry.

Experience :

Prior experience in the Medical Device and / or Pharmaceutical related industry desired.

Two years of experience in operations, engineering, and project evaluation.

One year of work experience in silicone processing and / or silicone device manufacturing.

Experience working with FDA GMP's.

Training :

Training requirements for this position are called out in the Required Employee Training Matrix.