As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.

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 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.

Position: 

Manager, Advanced Process Engineering

Department: 

Advanced Process Engineering

Reports to: 

VP of Engineering / R&D

Summary:

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 sustaining engineering resources and projects.  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 position as a US-based manufacturer.

Qualifications:

• Bachelor degree in an engineering or technical discipline.
• At least 7 years professional work experience in a manufacturing or engineering role and 3 years management experience in the medical device industry.
• Strong project management skills and the ability to prioritize and manage multiple tasks simultaneously; PMP certification is desirable.
• Lean Six Sigma Green Belt or higher. Six Sigma project management is a plus.
• Strong working knowledge of medical device manufacturing process including cleanroom assembly, electronics assembly, injection molding, extrusion, ultrasonic welding, RF forming/welding, solvent bonding, adhesive bonding.
• Excellent problem-solving and decision-making abilities, with a focus on continuous improvement.
• Demonstrated experience with Root Cause Analysis and DOE.
• Experience designing and developing process design requirements, and validating processes and equipment to meet those requirements. Demonstrated experience with automation equipment and PLC programming software is preferred.
• Advanced computer skills using MS Office applications, SolidWorks (or other 3D modeling software) and Minitab statistical analysis.
• Excellent writing, technical, and problem solving skills in the necessary engineering disciplines.
• Knowledge of FDA, ISO 13485, and EU MDR requirements.
• Excellent interpersonal skills to collaborate effectively with cross-functional teams and communicate with all levels of the organization.

Responsibilities:

• Plan and manage financial and personnel resource priorities for sustaining engineering projects to meet established company goals.
• Actively manage engineering personnel to attain individual professional growth in areas of engineering, manufacturing, quality, safety, project management and clinical application by providing the motivation and opportunity to obtain further training.
• Provide on-going engineering support to resolve component, process, design or equipment problems affecting production or quality; coordinate the execution of specific projects intended to improve efficiency and quality, increase capacity and reduce costs. Facilitate 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 domestic and international design control regulations.
• Work closely with R&D, Sales, Marketing, and Quality to support new product development efforts. Provide technical leadership within the design transfer and manufacturing start-up stages of NPD.
• Provide technical resources to Marketing in support of customer training, problem resolution and new project identification.
• Manage all aspects of process automation and new manufacturing technology program transitioning to world-class manufacturing supporting safety, quality, delivery and cost. Develop in-depth financial and technical analysis to define and support long-term direction of new manufacturing technology program & strategy.
• Collaborate with engineering, maintenance & manufacturing teams to ensure optimal functionality and availability of manufacturing equipment and facilities. Identify equipment needs, evaluate new technologies, and make recommendations for equipment upgrades or replacements to improve efficiency and capacity.
• Establish and monitor department 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 guidance and recommendations to the Continuous Improvement program.
• Actively contribute to the CAPA program through leadership and guidance of 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 domestic and international regulatory requirements.
• Support supply chain processes through supplier evaluation, qualification and resolution of corrective actions. Provide technical support to the supplier audit team.
• Develop, fabricate, qualify, and implement new process technology and equipment to support automation program.

Notables / Benefits:

• Summer hours available
• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation and other excellent benefits

An Equal Opportunity Employer