Open Position: Sr. Technician (Test Engineer) 

Function: Engineering 

Summary

EdgeOne Medical is an ISO 13485 certified Contract Development Organization specializing in the development and testing of medical devices and device combination products. EdgeOne is seeking an individual who applies a solid understanding of laboratory testing skills sets toward the testing of new medical device and/or combination (drug + device) products, such as syringes, autoinjectors, inhalers, vial access devices, and pumps.  Generates test data in support of test method validations, design verification and characterization studies.

Kindly note: This position is on-site in Wheeling, IL, and we are currently considering local candidates only. Relocation assistance is not available for this role.

Please send your resume and a cover letter to careers@edgeonemedical.com and include Sr. Technician (Test Engineer) in the Title. 

Essential Duties and Responsibilities

  • Reliably executes testing programs per specified methodologies captured within protocol or test method standard operating procedure in an accurate and repeatable manner.
  • Documents data generated per test method onto applicable data sheets per Good Laboratory Practices (cGLP) and Good Documentation Practices (cGDP)
  • As needed, can support development and refinement of test method set-up/fixturing as required by client needs or per guidelines provided within ISO standard.
  • Assures adherence to Quality System and ensures Good Laboratory Practices (cGLP) and Good Documentation Practices (cGDP) are followed
  • Maintains a culture of continuous improvement while accelerating delivery of commitments.
  • Stays up-to-date on manipulation of testing equipment (Force tests, Torque test, Measurement equipment, etc.)

Qualifications

To perform this job successfully, the candidate must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Demonstrated ability through education or previous employment:

  • Associates or Bachelor’s Degree in Science or Engineering. (Mechanical or Biomedical preferred.)
  • 2-4 years of experience in medical device testing laboratory.
  • Has familiarity operating a variety of testing equipment such as: tensile testers (Instron, MTS, Zwick), optical measurement systems (Micro-vu, Keyence), balances (analytical, top-loading), pressure/leak test systems, visual inspections by eye or digital microscope (HiRox, Keyence), various force and torque meters (Mark-10, Omega), Container Closure Integrity Testers (High Voltage Leak Detection, Vacuum decay, Helium leak decay, Headspace analysis, Dye ingress)
  • Well-versed in GLP and GDP requirements.
  • Versed in writing and executing protocols and reports.
  • Highly motivated self-starter who works well within team environment.
  • Hands on individual with high attention to detail during testing and documentation of results.
  • Ability to assess and diagnose unusual behavior of a test sample, with support from experienced engineering peers and managers. For example, speculating/demonstrating how a device manufacturing process issue or design flaw might have contributed to unexpected test sample performance.
  • Ability to problem solve, develop test systems, and maintain laboratory equipment.
  • Working knowledge of Microsoft Word and Excel.
  • Working knowledge of statistical data analysis and Minitab preferred, especially GR&R.
  • Experience with automated data collection by LabVIEW or similar software is beneficial.

Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.