Sr. Process Engineer

Position Summary

The Senior Process Engineer to champion daily manufacturing performance and long-term operational improvements. This role is deeply embedded on the production floor-driving process capability, refining tooling and process concepts, mentoring technical staff, and enabling cost-effective, high-quality production. You will oversee technical projects from early definition through implementation, always with an emphasis 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/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.
• Conducts 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/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.
• Demonstrates 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.