Description: I. SUMMARY:
This document outlines the employment prerequisites and job responsibilities for the Technician, Test Engineering position.
II. ESSENTIAL FUNCTIONS:
This position is involved in various aspects of the Test Engineer lab and works collaboratively with various departments and engineers to ensure test plans are implemented effectively and in a timely manner.
Develop test plans that adequately depict the methods and techniques necessary to examine or validate SIGMA medical device designs to required specifications.
Review appropriate or mandated agency specifications and structure device test plans in accordance with required specifications.
Conduct or supervise Engineering testing while implementing techniques that reduce or eliminate unwanted product variables.
Work with Mechanical and Electrical Engineers to develop device specifications based on characterization data of device(s) under test.
Document test results with formal Engineering Reports.
Analyze or investigate product complaints as directed in an effort to support device/customer product application.
Use electronic or mechanical instrumentation including, but not limited to: data acquisition systems, multi-meters, chart recorders, scales, pressure transducers, air gauge, and optical comparator for the purpose of obtaining data from the device or system under test.
Participate in design reviews as required.
Work with certification agencies such as UL and CSA to acquire certification for product submissions of medical devices.
Perform other duties as assigned.
III. QUALIFICATIONS, KNOWLEDGE, EDUCATION AND SKILLS REQUIRED:
Possess strong written and verbal communication skills
Capable of holding strict confidentiality and discretion.
Must be adaptable and quick to learn and embrace new practices/procedures, technologies, as well as manage communications effectively among diverse groups of people within an organization.
Knowledge and working application of standard operating procedures.
Ability to work in a manufacturing environment with a fast pace, changing priorities and deadlines.
Basic computer skills such as word processing, data entry and e-mail
Basic science and/or math skills
IV. EDUCATION/EXPEREINCE REQUIRED
High School Diploma or equivalent
A.S/A.A.S. Degree in a technical field of study is preferred.
Familiarity with FDA, electrical safety agencies and/or ISO 9000 design requirements is desired.
Experience in Statistical Methods/Theories/Studies/DOE, etc., is also desirable
No years of experience are needed.
V. 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 the 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:
Must be able to stand, sit and walk throughout the work day.
must have good hand to eye coordination and dexterity
VI. WORK ENVIRONMENT:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
Wearing a static protective smock at all times while in the work area
Wearing a ground wrist strap and plugging that wrist strap into the working table.
Working in close proximity to other employees.
Working in an environment that is temperature and humidity controlled.
Working in test environments where the temperature/humidity fluctuates as part of the product test plan.
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.