NPD Process Engineer

Job Overview

Norwood Medical is seeking a Process Engineer in New Product Development in Dayton, Ohio, with a contract employment type. The role focuses on translating customer specifications into robust CNC machining processes (multi‑axis turning and milling), ensuring DFM, leading production ramp‑up, and documenting process validation (IQ/OQ/PQ) in accordance with FDA/ISO 13485.

• Lead the development of scalable, cost‑effective manufacturing processes for new medical products, with a primary focus on multi‑axis CNC turning and milling.
• Collaborate with customers and internal engineering teams during design to provide manufacturability feedback and ensure tolerance compliance.
• Select and justify equipment, tooling, fixtures, and gauges; develop CNC programs, set‑up sheets, and work instructions for initial production runs.
• Execute and document process validation activities, including IQ/OQ/PQ, per FDA/ISO 13485 requirements.
• Conduct PFMEA to identify and mitigate manufacturing risks.
• Identify and resolve technical production issues during pilot and validation runs; drive continuous improvement.
• Estimate manufacturing costs and cycle times to support quoting and business development.
• Manage assigned NPI projects, ensuring milestones are met on time and within budget.

• Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related field.
• 3‑5 years of experience as a Process, Manufacturing, or CNC Engineer, mainly in NPI or development.
• Hands‑on knowledge of CNC machining (Swiss turning, multi‑axis milling, grinding).
• Proficiency in CAD/CAM (Solid Works, Mastercam, Esprit) for tooling design and CNC programming.
• Strong understanding of GD&T and metrology.
• Experience in a regulated environment (ISO 13485, FDA CFR 820) with process validation and documentation.
• Proficiency in SPC and problem‑solving methodologies (Six Sigma, 8D).
• Preferred: experience with automated or robotic machine‑tending systems; familiarity with secondary processes such as cleaning, deburring, passivation, or heat‑treating.

Located in Dayton, Ohio, Norwood Medical is a contract medical device manufacturer supporting customers in robotic‑assisted surgeries, orthopedics, and minimally invasive surgery markets. We focus exclusively on medical device manufacturing and are dedicated to quality and cutting‑edge technology.

• Paid time off and holidays.
• Medical, dental, vision, and employer‑paid life insurance.
• 401(k) match.
• Climate‑controlled environment.
• Career advancement training and opportunities.

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