Process Engineer

Position Summary

The Process Engineer will be responsible for the development and execution of select technical operations including the establishment of process parameters, support of validation activities, and troubleshooting production issues in a manufacturing facility. The role includes planning, designing, developing, and maintaining programs, training, and manufacturing processes such as braiding, assembly, tipping, reflow, and centerless grinding. The position will also provide direction and support for existing products and facilitate efficient operations within the production area, optimize processes, and ensure production goals are met.

• Utilize engineering principles to establish capable processes for new and existing tooling including the use of modeling tools
• Serve as a Subject Matter Expert (SME) for catheter assembly processes
• Support adjacent catheter manufacturing technologies such as braiding, coil winding, polymer reflow, and catheter tipping
• Standardize and support set‑up procedures and standard tools to continuously reduce set‑up times
• Work with cross‑functional teams to support production transfers
• Develop, model and document processes that demonstrate the achievement of functional, financial, and quality goals
• Participate in the development of validation protocols in cooperation with Quality, Sales, and Operations functions
• Execute comprehensive OQ protocols that define, demonstrate, and document process windows sufficient to achieve Process Capabilities that meet or exceed Customer’s and/or Cretex Process Capability requirements on critical to quality features
• Support the Quality team while they execute comprehensive PQ protocols that define, demonstrate, and document process windows sufficient to achieve Process Capabilities that meet or exceed Customer’s and/or Cretex Process Capability requirements on critical to quality features
• Identify and support continuous improvement opportunities for processes that are performing below Cretex quality standards
• In collaboration with Quality, analyze weekly yield and inspection data to identify and resolve problem processes and tools
• In collaboration with Operations, analyze weekly delivery and productivity data to identify and resolve problem processes and tools
• Provide technical coaching and feedback to production employees and the support team
• Communicate with customers as necessary regarding technical details of individual assembly processes and validation process
• Partner with the other business segments sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets served
• Ensure business systems are implemented, maintained, and functioning properly
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing environment
• Bachelor’s degree in Engineering or related field, or equivalent training and experience
• 3‑5 years of experience in a related manufacturing environment
• Medical device catheter assembly experience
• Ability to read and understand quality plans
• Must possess the ability to troubleshoot issues using disciplined root‑cause analysis tools
• Understanding of a variety of catheter assembly processes and secondary operations equipment
• Depth of knowledge in material and material grades for polymer reflow, sizing and its interactions during assembly
• Strong Leadership skills
• Ability to consistently achieve short‑ and long‑term business results
• Ability to follow through on commitments and hold team members accountable
• Strong problem‑solving skills
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast‑paced team environment
• Ability to prioritize and multitask
• Ability to travel outside the US 10% of the time

• Continuing…