Medical Device NPI Lead | Cross-Functional Launch

Marmon Holdings, Inc.; Angola (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

Precision Edge Surgical Products Company LLC is seeking a Manager of New Product Introductions (NPI) to lead the engineering team in transferring new medical device products from development into commercial manufacturing. You will liaison across functions to ensure on-time launches within budget and regulatory compliance.

The ideal candidate has extensive medical device product development and manufacturing operations experience, strong project management skills, and proven leadership in a

Qualifications

• Bachelor’s degree in engineering and 10–15 years in medical device manufacturing.
• Experience with ISO 13485 and 21 CFR 820.
• Proven supervisory experience leading cross-functional teams.
• Ability to use SolidWorks and ERP/workflow tools.

Responsibilities

• Lead engineering team through transfer of new products to manufacturing.
• Coordinate with Business Development, Quality, Procurement and Supply Chain.
• Manage NPI process from customer request to launch.
• Ensure regulatory compliance and budget adherence.
• Develop prototype processes and training.

Skills

NPI management

Cross-functional leadership

Project management

Quality systems

Leadership

Education

Bachelor’s degree in engineering

Tools

SolidWorks

ERP software

Smartsheet

SharePoint

Job description

Precision Edge Surgical Products Company LLC is seeking a Manager of New Product Introductions (NPI) to lead the engineering team in transferring new medical device products from development into commercial manufacturing. You will liaison across functions to ensure on-time launches within budget and regulatory compliance.

The ideal candidate has extensive medical device product development and manufacturing operations experience, strong project management skills, and proven leadership in a