Medical Device Commercialization Manager

Our client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives.

The New Product Development Manager leads the development and industrialization of surgical consumable products — such as disposable instruments, delivery systems, and sterile components — ensuring regulatory compliance, cost efficiency, and scalable manufacturability.

This role connects R&D innovation, process development, and quality-compliant manufacturing to bring new medical devices from concept to market-ready production.

Key Responsibilities

1. Product Development & Industrialization

• Lead the end-to-end NPD process for surgical consumables — from concept design and prototyping to process validation and market release.
• Translate clinical and user needs into robust design specifications, aligned with technical and commercial goals.
• Ensure design transfer to manufacturing by developing scalable and validated production processes (ISO 13485, FDA 21 CFR 820).
• Oversee creation and maintenance of Design History Files (DHF), Device Master Records (DMR), and Risk Management Files (ISO 14971).
• Coordinate material selection, supplier qualification, and validation for injection molding, extrusion, or assembly of polymer-based consumables.

2. Scale-Up & Manufacturing Readiness

3. Regulatory and Quality Compliance

4. Cross-Functional Project Leadership

5. Continuous Improvement & Innovation

Candidate Profile

Technical Skills