NEW PRODUCT INTRODUCTION (NPI) MANAGER

Precision Edge Surgical Products Co; Angola (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Precision Edge Surgical Products Company LLC is seeking an experienced NPI Manager to lead engineering teams through transferring new medical devices from development to commercial manufacturing. You will coordinate across Business Development, Quality, Procurement, and Supply Chain to ensure on-time, on-budget launches in a regulated environment.

The ideal candidate will have 10-15 years in medical device contract manufacturing, fabrication, and product launches, with ISO 13485 and 21 CFR 820

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

Responsibilities

• Lead engineering team in the successful transfer of new medical device products from development into commercial manufacturing.
• Coordinate and manage the NPI process from customer request to product launch or launch handoff to onsite engineering teams.
• Work with Business Development, Quality, Procurement, Supply Chain, Operations, Accounting, and Procurement to meet company goals.
• Develop and maintain a formal prototype process utilizing nonproduction equipment.
• Create a team-based environment with a positive atmosphere.
• Assist annually with the budget setting process and strategic planning.
• Support Monthly Management Report (MMR) analysis and generation.
• Champion Health, Safety and Environment standards

Skills

CNC and automated manufacturing

Cross-functional leadership

Project management

Education

Bachelor’s degree in engineering

Advanced Degree in Engineering

Tools

SolidWorks

ERP software

Smartsheet

SharePoint

Job description

## NEW PRODUCT INTRODUCTION (NPI) MANAGERApplylocations: Angola, INtime type: Full timeposted on: Posted Todayjob requisition id: JR0000044153Precision 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 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**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 SolidWorks, navigate ERP software, utilize workflows such as Smartsheet and SharePointPreferred* Advanced Degree in Engineering* Experience in cost estimating and prototype processes**Reports To*** Director of Engineering and Quality**FLSA Status*** Salary ExemptFollowing 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.