Mt. Washington Pediatric Hospital
NPD Process (Manufacturing)
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 gauging.
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.
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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 gauging.
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.
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