NPD Process Engineer

Description

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.

Requirements