Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Electrical Engineer – direct hire / full-time
Engineering & Maintenance Director
Electronics Engineering / Operations
Allen, TX 75002
Supports activities associated with manufacturing support, process improvement, validation, QA reports, and technology; product development and/or transfer; primarily dealing with electrical sub-systems.
Bachelor’s degree (B.S.) and minimum of five years in the medical device manufacturing industry or related experience, or
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 members.
Ability to read, analyze, and interpret common scientific and technical journals.
Effective verbal and written communication skills in conveying technical issues in drafting documents for review and approval by management.
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 concrete variables.
Strong planning and organizational skills to meet project timelines, budgets while meeting customer and product needs and requirements.
Performs duties and responsibilities under indirect supervision.
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 testing.
Investigates, tests, compiles and corrects test failures seen in instruments and printed circuit boards, down to the component level.
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 assembly.
Drafts qualification and validation documents to support electrical test process/equipment changes.
Drafts engineering change order reports and non-conforming material reports.
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 analysis.
Ability and willingness to work interdepartmentally with QA/RA to ensure full adherence to Quest’s Quality Management System (QMS).
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 practices.
Notables / Benefits:
Mid-size company with great company culture that is well diverse
Have a voice in the company
Average tenure for employee population is 10+ years
401k with employee matching available
Paid vacation, health/dental/vision, and other excellent benefits