Product Introduction; Npi Manager

Position: NEW PRODUCT INTRODUCTION (NPI) MANAGER
Precision Edge Surgical Products Company LLCAs a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Position Summary 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.

The ideal candidate will have strong experience in medical device product development, manufacturing operations, project management, and cross-functional leadership within a regulated environment.

Key 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 non-production 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

Key Competencies 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 Qualifications Required 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 Solid Works, navigate ERP software, utilize workflows such as Smartsheet and Share Point Preferred Advanced  Degree in Engineering Experience in cost estimating and prototype processes

Reports To Director of Engineering and QualityFLSA Status Salary Exempt Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.
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