Director NPI Manufacturing – Medical Robotics – Capital Equipment – Pilot Line Architecture – Commercial Production Scale
Our client is a stealth‑mode Boston area medical robotics start‑up developing a first‑generation medical capx platform capable of disrupting current standard of robotic‑assisted diagnostic and therapeutic procedures.
We are seeking a dynamic and experienced Director of NPI Manufacturing to lead the development, scaling, and implementation of pilot manufacturing and commercial production strategies for our client's breakthrough medical robotic platform.
This new key executive leader will spearhead all manufacturing architecture and strategy guiding this 1st of its kind medical robotic concept from prototype through advanced pilot manufacturing process design, quality assurance, supply chain management, onward through commercial‑scale global production.
Key Responsibilities
Develop and execute the manufacturing strategy, aligning with product development and commercialization goals.
Build and lead a high‑performing manufacturing team, fostering a culture of innovation and excellence.
Oversee the design and establishment of manufacturing facilities, processes, and systems to ensure scalability.
Collaborate with R&D to optimize designs for manufacturability, cost‑effectiveness, and quality.
Drive supplier and vendor selection, negotiations, and management to ensure robust supply chain operations.
Establish and maintain rigorous quality systems and processes to meet regulatory requirements (e.g., FDA, ISO 13485).
Implement lean manufacturing and continuous improvement initiatives to drive operational efficiency.
Ensure the company is prepared for successful audits, inspections, and certifications as required.
Qualifications
Bachelor’s degree in engineering, manufacturing, or a related field; advanced degree preferred.
10+ years of progressive leadership experience in manufacturing, with a focus on medical devices, robotics, or other highly regulated industries.
Proven experience scaling manufacturing operations from prototype to commercial production.
Deep knowledge of quality systems, regulatory compliance, and industry standards (e.g., FDA, ISO 13485).
Strong background in lean manufacturing, supply chain management, and cost optimization.
Exceptional leadership, communication, and organizational skills.
Track record of building and scaling teams in a fast‑paced, entrepreneurial environment.
Seniority level
Director
Employment type
Full‑time
Job function
Manufacturing, Supply Chain, and Production
Industries
Medical Equipment Manufacturing
Manufacturing
Machinery Manufacturing
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Director Manufacturing • Boston, Massachusetts, United States