NEW PRODUCT INTRODUCTION (NPI) MANAGER

The Manager of New Product Introductions (NPI) is responsible for leading the engineering team in the successful transfer of new medical device products from development into commercial manufacturing. This role serves as a key liaison between Business Development, Quality, Procurement, Supply Chain, Manufacturing, Accounting, and external suppliers to ensure products are launched on time, within budget, and in compliance with applicable regulatory requirements.

Responsibilities

Manages the quoting process across the Marmon Medical Manufacturing (MMM) Platform; Manages customer expectations with new products including, up front design work, medical device performance, Design for Manufacturability (DFM); Coordinates and manages the NPI process from customer request to product launch or launch handoff to onsite engineering teams; Understands manufacturing processes and process capabilities across all MMM manufacturing sites; Works closely with Business Development, Engineering, Quality, Supply Chain, Operations, Accounting, and Procurement to meet company goals; Develops and maintains a formal prototype process utilizing nonproduction equipment; Create a team-based environment with a positive atmosphere; Ensure that personnel are trained for their job positions and have relevant goals established that align with company goals; Assists annually with the budget setting process and strategic planning; Supports Monthly Management Report (MMR) analysis and generation; Champion for Health, Safety and Environment standards

Requirements

Bachelor's degree in engineering; 10-15 years' experience in medical device contract manufacturing, product development and production launch; Knowledge of ISO 13485 and 21 CFR 820; Supervisory experience leading teams; Ability to use SolidWorks, navigate ERP software, utilize workflows such as Smartsheet and SharePoint; Strong experience in medical device product development, manufacturing operations, project management, and cross-functional leadership within a regulated environment; Strong background in CNC and automated manufacturing processes; New product release (NPR); Estimating; Collaboration; Customer Focus; Technical support; Resource Management; Change Management; Project Management; Effective leadership; Coaching and Employee Development; Strategic Planning; Problem Solving Skills

Nice to have

Advanced Degree in Engineering; Experience in cost estimating and prototype processes