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:
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.
- 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