Norwood Medical
Description
Norwood Medical is a leading contract manufacturer of precision medical components and assemblies located in Dayton, Ohio. We specialize exclusively in the medical device industry, supporting innovations in robotic-assisted surgery, orthopedics, and minimally invasive procedures. Our continued growth is driven by a commitment to quality, advanced technology, and operational excellence.
We are seeking a skilled and driven
Process Engineer
to join our
New Product Development (NPD)
team. This role is responsible for the development, validation, and implementation of efficient, high-quality manufacturing processes for new medical components and assemblies. The Process Engineer will interface cross-functionally with R&D, Quality, Program Management, and Customer Engineering teams to ensure manufacturability and successful product launch.
Key Responsibilities: Develop and implement CNC machining and manufacturing processes for new product introduction (NPI), including machine tool selection, fixture design, tooling specification, and process development. Conduct process capability studies, root cause analyses, and cost analyses to validate and refine manufacturing strategies. Provide technical guidance on design for manufacturability (DFM), collaborating directly with internal and external engineering teams. Define and document standard operating procedures (SOPs), work instructions, and training protocols for developed processes. Support prototype builds and pilot production runs, ensuring process repeatability and scalability. Apply statistical process control (SPC) methods and data-driven decision making to improve and stabilize new processes. Lead or support validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Interface with supply chain and procurement to support tooling and materials sourcing for new processes. Requirements
Bachelor's degree in Engineering or related technical field with a minimum of 5 years of relevant experience; equivalent combination of education and experience will be considered. Proven experience in a manufacturing environment, preferably within medical device or precision components. Strong knowledge of CNC machining processes (3/4/5-axis machining centers, Swiss turning, mill-turn lathes). Proficiency in interpreting engineering drawings and GD&T. Solid understanding of process capability analysis, root cause methodologies (5 Whys, Fishbone, etc.), and lean manufacturing principles. Ability to communicate complex technical concepts effectively to both internal stakeholders and customers. Experience in metal forming (e.g., swaging, stamping) and/or secondary operations such as laser welding, passivation, deburring, electropolishing, or ECM. Familiarity with CAD and CAM tools (e.g., SolidWorks, Mastercam) for tooling and process design. Experience with data acquisition, DOE, and statistical software tools (e.g., Minitab). Prior involvement in medical device product development under ISO 13485 and FDA QSR guidelines is highly desirable
Norwood Medical is a leading contract manufacturer of precision medical components and assemblies located in Dayton, Ohio. We specialize exclusively in the medical device industry, supporting innovations in robotic-assisted surgery, orthopedics, and minimally invasive procedures. Our continued growth is driven by a commitment to quality, advanced technology, and operational excellence.
We are seeking a skilled and driven
Process Engineer
to join our
New Product Development (NPD)
team. This role is responsible for the development, validation, and implementation of efficient, high-quality manufacturing processes for new medical components and assemblies. The Process Engineer will interface cross-functionally with R&D, Quality, Program Management, and Customer Engineering teams to ensure manufacturability and successful product launch.
Key Responsibilities: Develop and implement CNC machining and manufacturing processes for new product introduction (NPI), including machine tool selection, fixture design, tooling specification, and process development. Conduct process capability studies, root cause analyses, and cost analyses to validate and refine manufacturing strategies. Provide technical guidance on design for manufacturability (DFM), collaborating directly with internal and external engineering teams. Define and document standard operating procedures (SOPs), work instructions, and training protocols for developed processes. Support prototype builds and pilot production runs, ensuring process repeatability and scalability. Apply statistical process control (SPC) methods and data-driven decision making to improve and stabilize new processes. Lead or support validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Interface with supply chain and procurement to support tooling and materials sourcing for new processes. Requirements
Bachelor's degree in Engineering or related technical field with a minimum of 5 years of relevant experience; equivalent combination of education and experience will be considered. Proven experience in a manufacturing environment, preferably within medical device or precision components. Strong knowledge of CNC machining processes (3/4/5-axis machining centers, Swiss turning, mill-turn lathes). Proficiency in interpreting engineering drawings and GD&T. Solid understanding of process capability analysis, root cause methodologies (5 Whys, Fishbone, etc.), and lean manufacturing principles. Ability to communicate complex technical concepts effectively to both internal stakeholders and customers. Experience in metal forming (e.g., swaging, stamping) and/or secondary operations such as laser welding, passivation, deburring, electropolishing, or ECM. Familiarity with CAD and CAM tools (e.g., SolidWorks, Mastercam) for tooling and process design. Experience with data acquisition, DOE, and statistical software tools (e.g., Minitab). Prior involvement in medical device product development under ISO 13485 and FDA QSR guidelines is highly desirable