Medical Device NPI Lead: Launch & Manufacturing Transfer

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

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.