Company: Quest Medical, Inc.
Posted on: August 2, 2022
Summary:Supports activities associated with manufacturing
support, process improvement, validation, QA reports, and
technology; product development and/or transfer; primarily dealing
with electrical sub-systems. Requirements:
- Bachelor's degree (B.S.) and minimum of five years in the
medical device manufacturing industry or related experience,
- Master's degree (M.S.) and minimum of three years in the
medical device manufacturing industry or related experience.
- Ability to prioritize multiple projects from different areas
(production and R&D).
- Lead and mentor both indirect reports and cross-functional team
- Ability to read, analyze, and interpret common scientific and
- Effective verbal and written communication skills in conveying
technical issues in drafting documents for review and approval by
- Ability to define problems, collect data, establish facts and
draw valid conclusions.
- Ability to interpret and edit an extensive variety of technical
information in mathematical or diagram form, including editing or
changing printed circuit board layout, Bill of Materials and
schematic information (PADS, OrCAD or Gerber Data).
- Ability to communicate complex problems for understanding to
non-technical personnel dealing with several abstract and/or
- Strong planning and organizational skills to meet project
timelines, budgets while meeting customer and product needs and
- Performs duties and responsibilities under indirect
- Identifies, justifies and implements equipment upgrades, new
product and process technologies, and process improvements for
electro-mechanical and electrical testing of printed circuit boards
and assemblies, including LabVIEW based testing and in-circuit
- Investigates, tests, compiles and corrects test failures seen
in instruments and printed circuit boards, down to the component
- Ability to troubleshoot issues to the component level using
logic analyzers, oscilloscopes, multi-meters based on information
presented in design input or output documents, such as engineering
specifications, schematics and bills of material.
- Knowledge of requirements for cGMP compliance, ISO13485
compliance, design control, and process validation.
- Performs analysis of data and can communicate those results in
a technical report or design review.
- Performs root cause analysis and recommends resolution of
problems associated with products, manufacturing processes,
customer complaints and non-conforming material reports.
- Ability to interact with electrical or electro-mechanical
component suppliers to relay issues uncovered at Quest and to
arrive at a technical solution. Included is the ability to distill
the operation of the Console down to the requirements placed on a
particular component and how it reacts, or fails, within the final
- Drafts qualification and validation documents to support
electrical test process/equipment changes.
- Drafts engineering change order reports and non-conforming
- Supports, coordinates, and/or leads projects requiring the
participation of suppliers, cross-functional team members, and
consultants to improve processes/products.
- Possess technical writing, project management, fundamental
problem-solving skills, and maintain lab notebooks.
- Ability to apply advanced mathematical concepts and statistical
- Ability and willingness to work interdepartmentally with QA/RA
to ensure full adherence to Quest's Quality Management System
- Research, evaluate, and justify to Senior Leadership the
selection of component suppliers relating to product development
and process improvements.
- Familiarity with Kaizen, 5S, Gemba and other Lean manufacturing
An Equal Opportunity Employer
Keywords: Quest Medical, Inc., Allen , Electrical Engineer, Professions , Allen, Texas
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