Cerro de Pasco Resources Inc. · Indiana
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Precision Edge Surgical Products Company LLC
As 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 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
[email protected], and please be sure to include the title and the location of the position for which you are applying.