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NPI Launch Manager
Job in
Santa Clara, Santa Clara County, California, 95053, USA
Listed on 2026-03-01
Listing for:
BN Associates Inc.
Full Time
position Listed on 2026-03-01
Job specializations:
-
Engineering
Manufacturing Engineer -
Manufacturing / Production
Manufacturing Engineer
Job Description & How to Apply Below
Experience:
10–15+ years in Med Tech product launch, equipment qualification, and process engineering
We are seeking a seasoned NPI Launch Manager to lead the design-to-launch lifecycle of Med Tech capital equipment, including surgical devices, robotics, and electromechanical systems. This fully onsite role in Raynham requires a proven leader with deep expertise in new product introduction, factory setup, lean manufacturing, and advanced automation. The ideal candidate will bring thought leadership, cross-functional collaboration, and a track record of delivering world-class solutions in regulated environments.
Key Responsibilities- Lead end-to-end NPI launches from design to commercialization for Med Tech capital equipment.
- Drive equipment qualification (FAT, SAT, IQ, OQ, PQ) and ensure compliance with ISO
13485 and FDA standards. - Establish and consolidate manufacturing plants, applying lean manufacturing principles.
- Design and implement manufacturing & warehouse layouts, leveraging advanced simulations for factory performance and supply chain scenarios.
- Oversee large-scale inventory sizing, material planning, and warehouse optimization.
- Implement automation systems for assembly, inspection, and testing.
- Apply AI-driven solutions in manufacturing, quality testing, and automation.
- Build data-driven, connected platforms for manufacturing operations, integrating Industry 4.0 elements.
- Collaborate with cross-functional leaders, customers, and offshore teams to expand business avenues.
- Develop and mentor high-performance teams, delivering projects in world-class environments.
- 10–15 years of experience in Med Tech NPI launches, equipment qualification, and process engineering.
- Strong expertise in ISO
13485 compliance and regulated product launches. - Proven success in factory setup, lean manufacturing, and plant consolidation.
- Hands-on experience with automation systems, AI applications, and Industry 4.0 platforms.
- Excellent leadership, communication, and stakeholder management skills.
- Ability to collaborate with global teams and drive customer engagement.
- Experience with leading Med Tech companies (e.g., Intuitive Surgical, Medtronic, Stryker Robotics).
- Background in surgical devices, robotics, and electromechanical systems.
- Demonstrated success in scaling NPI programs to global markets.
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