NEW PRODUCT INTRODUCTION (NPI) MANAGER

Precision Edge Surgical Products Company LLC; Angola (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Marmon is seeking a Manager of New Product Introductions to lead the engineering team in transferring new medical device products from development to commercial manufacturing. You will coordinate with Business Development, Quality, Procurement and Supply Chain to ensure on-time launches within budget and regulatory compliance.

The role requires strong experience in medical device development, manufacturing operations, and cross-functional leadership within a regulated environment.

Qualifications

• Bachelor's degree in engineering required.
• 10–15 years in medical device contract manufacturing, product development and production launch.
• Knowledge of ISO 13485 and 21 CFR 820.
• Supervisory experience leading teams.

Responsibilities

• Lead the NPI process from customer request to product launch or handoff to onsite engineering teams.
• Manage quoting across Marmon Medical Manufacturing Platform.
• Coordinate with Business Development, Quality, Procurement and Supply Chain to meet goals.
• Develop and maintain a formal prototype process using nonproduction equipment.
• Ensure personnel training and goal alignment with company objectives.
• Assist with budget setting and strategic planning.

Skills

NPI leadership

Cross-functional collaboration

Project management

Manufacturing operations

Strategic planning

Coaching and development

Problem solving

Leadership

Education

Bachelor's degree in engineering

Advanced degree in engineering

Tools

SolidWorks

ERP systems

Smartsheet

SharePoint

Job description

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.
• Understand(s) 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

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

• 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
• Preferred Advanced Degree in Engineering
• Experience in cost estimating and prototype processes

Reports To

Director of Engineering and Quality

FLSA 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 [e-mail], and please be sure to include the title and the location of the position for which you are applying.

Welcome to the biggest small business you’ll ever find. Part of Berkshire Hathaway, Marmon is a global industrial organization made of 11 industry groups with 30K employees and $12 billion in annual revenue. As leaders in their respective industries, our 120+ companies thrive on an independent mindset and entrepreneurial spirit. At the same time, they benefit from being part of our industry groups—where they’re able to tap into the expertise and insights of other Marmon companies. While we’re all unique, we all share a common commitment to doing things that matter, leading at every level, and winning a better way.

Kate Suprenuk Appointed President of Marmon Rail