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.
Director, Advanced Engineering & Maintenance – direct hire / full time
Advanced Process Engineering
Allen, TX 75002
Responsible for managing sustaining engineering, process development, and product design improvement efforts, including managing the financial and technical resources to accomplish high sustaining engineering support levels, advancement of process development through new technology, and product design improvement projects. Responsible for all plant Engineering and Maintenance resources. Core deliverables include production support, product/process improvements, cost reduction, and CAPA support. Responsible for long-term development of new manufacturing technology, automation, and machine integration. Focus on employee development to build strong teams and a pipeline of talent. Focus on technology development to improve manufacturing processes and maintain position as a competitive US manufacturer.
Bachelor degree in an Engineering or technical discipline.
At least 7 years professional work experience in a manufacturing or engineering role and 3 years supervisory experience preferably in the medical device industry.
Advanced problem solving experience and track record
Advanced computer skills using MS Office applications and statistical analysis
Excellent writing, technical, and problem solving skills in the necessary engineering disciplines
Knowledge of QSR and ISO regulatory requirements
Ability to communicate effectively at all levels.
Manage and plan resource priorities for sustaining engineering projects by understanding customer requirements and establishing goals with efficient execution. Actively manage resource loading activities within department to meet timeline commitments and goals.
Work closely with R&D, Marketing, and Quality to support new product development efforts. Provide technical leadership within the design transfer and manufacturing start-up stages of NPD.
Actively manage Engineering personnel to the attainment of individual professional growth in areas of engineering, manufacturing, management and clinical application by providing the motivation and opportunity to obtain further training.
Manage financial and engineering resources to support products and projects according to planned schedules. Identify product opportunities and collaborate with Marketing on market analysis.
Provide on-going engineering support to resolve component, process, design or equipment problems affecting production; coordinating the execution of specific projects intended to improve yields, increase capacity and reduce costs. Facilitate cost reduction and product improvement opportunities through the identification and assessment of high quality, cost competitive suppliers and process improvements.
Develop a project-based operating plan and yearly budget
Responsible for implementing design control activities and for ensuring all project activities are compliant with FDA design control regulations.
Provide technical resources to Marketing in support of customer training, problem resolution and new project identification.
Manage process automation and new manufacturing technology program, supporting cost containment efforts across the key product lines. Develop in-depth financial and technical analysis to define and support long-term direction of new manufacturing technology program.
Responsible for the management of an effective Maintenance Program supporting the various production areas.
Align maintenance and engineering priorities to maximize the flow of continuous improvements.
Establish and monitor Maintenance KPI’s. Ensure teams take appropriate countermeasures to resolve and deficiencies.
Support Lean initiatives through participation on Kaizen Teams and adopt Lean principles into all process improvement activities. Provide leadership to the Continuous Improvement program.
Actively contribute to the CAPA program through participation on cross functional teams focused on customer complaint investigation and internal NCMR resolution.
Implement and actively enforce procedures that ensure that all products developed and marketed by Quest meet applicable FDA requirements
Support supply chain processes through supplier selection, qualification, resolution of SCAR issues, and the supplier audit program.
Development, fabrication, qualification, and implementation of new process technology and equipment to support new technology and automation program
Be an active, contributing member of the Quest Leadership Team to support company implementation of company’s core beliefs and completion of company goals.
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