NPD Process Engineer

Norwood Medical is seeking a Process Engineer in New Product Development. This is a critical technical role responsible for developing and implementing robust manufacturing strategies for new, customer-driven medical components. This role will heavily focus on translating customer specifications into efficient and repeatable CNC Machining processes, ensuring design for manufacturability (DFM), and leading the initial production ramp-up.

Key Responsibilities:

• Lead the development of comprehensive, scalable, and cost-effective manufacturing processes for new medical products, with a primary focus on multi-axis CNC turning and milling.
• Work closely with customer and internal engineering teams during the design phase to provide feedback on manufacturability, ensuring new products can be produced efficiently and meet required tolerances.
• Select, justify, and implement necessary equipment, tooling, fixtures, and gaging. Develop and optimize CNC programs, setup sheets, and work instructions for initial production runs.
• Execute and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in line with FDA/ISO 13485 requirements.
• Conduct Process Failure Mode and Effects Analysis (PFMEA) to identify and mitigate manufacturing risks associated with new processes.
• Identify and resolve technical production issues during the initial pilot and validation runs. Drive continuous improvement opportunities in new product processes.
• Estimate manufacturing costs and cycle times for new products to support quoting and business development activities.
• Manage assigned new product projects, ensuring milestones are met on time and within budget.

• Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field.
• Minimum of 3-5 years of experience as a Process, Manufacturing, or CNC Engineer, with significant time spent in a New Product Introduction (NPI) or Development environment.
• Deep, hands-on knowledge of CNC machining processes (e.g., Swiss-style turning, multi-axis milling, grinding).
• Proficiency in CAD/CAM software (e.g., SolidWorks, Mastercam, Esprit) for tooling design and CNC program generation.
• Strong understanding of GD&T (Geometric Dimensioning and Tolerancing) and metrology.
• Proven experience working in a regulated environment (ISO 13485, FDA CFR 820) with experience in process validation (IQ/OQ/PQ) and documentation.
• Proficient in statistical process control (SPC) and problem-solving methodologies (e.g., Six Sigma, 8D).
• Experience with automated or robotic machine tending systems is preferred
• Familiarity with other secondary processes like cleaning, deburring, passivation, or heat treating is preferred

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!

Our employees enjoy:

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