Summary: Validation Engineer responsible for creation and execution of verification and validation test protocols and reports for the IOS Software, Hardware, and Mechanical development groups. Additional responsibilites include creation and routing for approvals of Design Control documentation such as Design and Development Plans, Product / Software Requirements, and Risk Management Plans.
Essential duties and responsibilities include the following. Other duties may be assigned.
Protocol driven Verification/Validation and bench top testing of all IOS products. These products include software, mechanical and electrical components and products.
Familiarity with running software black box testing equipment.
Familiarity with running signal generation and oscilloscope equipment.
Familiarity with testing fixtures to suggest appropriate design for testing equipment.
Abliity to contribute to the electrical, mechanical, and software requirements and design of analog/digital patient simulator.
History with FDA and ISO audits so that they can help auditors find the proper documentation for the NeuroVision team products.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
Requirements: 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: Engineering degree or equivalent and 5-7 years related experience; or equivalent combination of education and experience. Medical Device experience is preferred.
Computer Skills: Proficient and accurate with “Black Box” software testing protocol execution, testing software such as LabView, Word, Excel, charting, flow charting, and graphs. Competency in navigating the Internet.