Senior Manufacturing Process Engineer

Position Summary

The Senior Manufacturing 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.
• Conduct DOE studies, process characterisation, 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.

• 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 moulding, 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 modelling 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.