Sr. Process Engineer

Position Summary

The Senior Process Engineer will champion daily manufacturing performance and long‑term operational improvements. Embedded on the production floor, the role drives process capability, refines tooling and process concepts, mentors technical staff, and enables cost‑effective, high‑quality production. The engineer oversees technical projects from early definition through implementation, focusing on practical improvements that stabilize, simplify, and enhance manufacturing operations.

• Promote a safety first mentality for all production areas, equipment, processes, and procedures.
• Provide guidance and day‑to‑day direction to technicians and engineers on assigned activities and best practices.
• Utilize lean process technology and automation during manufacturing execution to continuously improve the manufacturing environments, driving cost leadership, world‑class quality, and customer satisfaction.
• Collaborate with new product introduction teams to ensure seamless implementation of new process flows and assist with transfer activities.
• Complete projects, report status, and document lessons learned efficiently; utilize project management tools to establish timelines, action item lists, assignments, due dates, and milestones.
• Lead process validation activities, including IQ, OQ, and PQ for equipment, tooling, and processes.
• Develop or improve processes and sampling activities, as well as tooling and manufacturing concepts that meet customer expectations on cost, quality, and delivery.
• Lead process improvement and waste elimination efforts through the application of lean principles; actively participate in continuous improvement events.
• Conduct DOE studies, process characterization, and root‑cause analysis to establish and maintain robust process windows.
• May communicate with existing customers on changes to existing processes, conveying timelines, and managing validation activities related to the change.
• Apply statistical tools to establish and monitor capability and verify effectiveness of improvements.
• Lead investigations and drive NCR/MRB/CAPA actions to closure in partnership with Quality and Operations; execute approved changes via change control.
• Demonstrate all corporate values:
  • We think and act like owners.
  • We are bold in our aspirations while moving forward with humility and integrity.
  • We are committed to making our customers successful.
  • We foster inspired teams.

• Bachelor of science in a related engineering field from a four‑year college or university.
• 5+ years of engineering experience within a medical device or contract medical device manufacturing environment.
• Working knowledge of typical medical device manufacturing techniques (tipping, thermoplastic injection molding, and extrusion).
• Proficiency in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).
• Proven experience leading IQ/OQ/PQ and working to ISO 13485 / FDA 21 CFR 820.
• Practical experience using DOE, SPC, and Gage R&R; familiarity with control plans and PFMEA.
• Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus.
• Analytical and problem‑solving skills; detail‑oriented and able to produce accurate, professional documentation.
• Motivated and creative; operates effectively under pressure in a fast‑paced team environment.
• Excellent interpersonal skills with the ability to communicate needs and demands effectively.
• Drives continuous improvement and waste elimination through lean principles.

• The employee may be required to lift and/or move up to 25 pounds.
• The employee may be required to sit for extensive periods.

• The job is performed indoors in a variety of settings, including the office, manufacturing floor, and warehouse. Exposure to loud noises, dust, and dirt may occur. Protective safety clothing/gear may be required. Activities include extended periods of standing or sitting and extensive work with measuring devices and other machinery.