New Product Development Quality Engineer

Brief Description

Norwood Medical is a premier manufacturer of high-precision medical components, specializing in advanced CNC machining for life-saving technologies. As we continue to expand our innovation pipeline, we are seeking a detail-oriented Quality Engineer to join our New Product Development (NPD) Team. This is a critical role where engineering meets compliance. You will serve as the quality lead for new product launches, ensuring that every machined component—from prototype to full-scale production—meets the rigorous standards of the medical device industry.

Key Responsibilities

• Collaborate with design and manufacturing engineers to develop quality plans for new medical components.
• Lead and participate in Design and Process FMEAs to identify and mitigate potential failure modes in CNC machining processes.
• Oversee IQ/OQ/PQ activities for new equipment and validated processes.
• Develop inspection methodologies for complex geometries, including the use of CMM, vision systems, and precision hand tools.
• Ensure all project documentation complies with ISO 13485 and FDA 21 CFR Part 820 standards.
• Work with raw material and coating suppliers to ensure incoming components meet technical specifications.
• Utilize Six Sigma and Lean tools to optimize yields and reduce scrap during the transition from R&D to production.

Requirements

• Bachelor’s degree in mechanical engineering, industrial engineering, or a related technical field.
• 3+ years of quality engineering experience within the medical device industry.
• Strong understanding of GD&T (Geometric Dimensioning and Tolerancing) and its application in CNC machined parts.
• Hands-on experience with ISO 13485 and the CAPA process.
• Proficiency with statistical software (like Minitab) and experience with high-precision metrology equipment.
• AQSC Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt is a plus.

Summary

Located in Dayton, Ohio, Norwood Medical is a contract medical device manufacturer that supports our customers in robotic assisted surgeries, orthopedic, and minimally invasive surgery markets. Our success stems from our commitment to quality and embracing leading edge technologies in supplying precision-machined components, assemblies, and value-added processes. We exclusively focus on medical device manufacturing, and we are excited to continue our company growth!