Development Engineer

Development Engineer

Auburn, AL

Job Summary

Working under Process Development Manager’s guidance, the Development Process Engineer is responsible for
developing and implementing plasma deposition thin-film technology for manufacturing medical devices utilizing
electromechanical processes and devices. The Development Engineer identifies customer’s product needs, using solid
engineering problem-solving skills crafts solutions to meet those needs. Independent judgment is required to plan,
prioritize, organize a diversified workload, resolve problems, effect changes to manufacturing processes or
procedures, and react positively to internal and external customer demands. The engineer will maintain records of all
development activities related to products, processes, suppliers, and customers. Training technicians, engineers,
applications scientists, etc., on processes and principles associated with the technology when necessary.

Duties and Responsibilities

• Design and develop electromechanical processes, devices, and accessories medical devices
• Use established procedures to improve existing processes, continually optimizing to produce higher-quality
devices
• Conduct engineering testing, design and execute Designs of Experiments to verify and validate product quality
and efficacy
• Assist in the completion of new and existing product design validations
• Statistical Analysis, including SPC, ANOVA, T-Test, F-Test, capability studies
• Lead pFMEA sessions and lend support for dFMEA meetings
• Improve quality performance by identifying and eliminating the variation in the process
• Provide technical support for developed equipment used in various processes
• Work with program management and maintain transparency development and quality problems and solutions as
necessary
• Assist in the resolution, documentation, customer responses of development activity and customer complaints
• Transfer of technology from development to operations
• Ability to work within an ISO 13485 or 9001 Quality Management System environment
• Execute Engineering Change Notices from customers and internal sources
• Perform advanced quality planning functions, including Gage R&R & MSA, drawing reviews, capability studies,
production documentation approval, inspection plans
• Coordinate and assist in corrective and preventative action activities and solutions

Education and Experience

• 1-5 years process development engineering experience leading and participating in complex projects
• Bachelor’s Degree in Chemical, Electrical Engineering, Industrial Technology, or related area of study
• Experience/ knowledge with GMP, DEP,FDA and ISO13485
• An understanding and previous use of continuous improvement tools
• Ability to perform multiple tasks in a fast-paced environment
• Good interpersonal skills with the ability to deal with all levels in the organization while remaining customeroriented
• Applies proven technology independently
• Thin film technology, plasma processing, vacuum technology experience preferred
• Medical device manufacturing experience preferred

Physical Requirements

• Prolonged periods of sitting/standing/walking
• Standard forty (40) hour work week with additional time as needed to meet company objectives
• Minimal to no travel required (10% or less annually)
• Ability to access and navigate each department at the organization’s buildings to include walking to and from
offices/building sites, and climbing/descending stairs
• Ability to see with or without corrective lenses and distinguish color differences and depth perception for
product and safety issues
• Ability to hear and react to audible alarms from distances up to 150 feet
• Ability to lift/carry up to fifty (50) pounds