12 sep
|
Materialise
|
Cataluña
12 sep
Materialise
Cataluña
At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment — helping improve and save lives daily.
The Technical Portfolio
Manager for CMF Standard plays a strategic role in accelerating the development and commercialization of CMF standard devices by removing barriers and streamlining processes. This position oversees the creation of new products and enhancements within the CMF portfolio, ensuring that robust production processes are developed and optimized. The ideal candidate brings proven expertise in standard CMF devices or a comparable highly regulated medical device sector, along with strong competitive market knowledge to inform strategic decisions.
They are adept at leading organizational change, fostering collaboration, and embedding a culture of continuous improvement across multiple disciplines. Accelerate product development by resolving bottlenecks and streamlining workflows across R&D;, manufacturing, quality, and regulatory in different locations (HQ, France, and Brazil) Define a strategic direction for developing and providing the right offering alongside the market management team for the CMF standard portfolio Identify bottlenecks throughout innovation, design and development (prototyping, testing, and verification, validation), industrialization, and regulatory approval stages Collaborate with R&D;, manufacturing, regulatory,
and quality teams to implement optimized processes, especially regarding justification strategies towards notified bodies and national health agencies Conduct deep competitor analysis on the top CMF standard device players Translate competitor strategies into actionable improvements in product lifecycle management, operational efficiency, and launch timelines Lead a cross-functional change program for the CMF standard portfolio with the whole CMF business line, driving and supporting speed-to-market improvement initiatives Ensure alignment of acceleration initiatives with regulatory compliance and quality standards Integrate best-in-class logistics practices from industry leaders to enhance responsiveness and service quality globally Serve as the high-level central point of contact for all internal product and process projects, including acceleration initiatives across departments and for market requests Facilitate communication and coordination between operations, commercial teams, and leadership Minimum 10 years in CMF standard devices (implants and surgical instruments) or regulated medical devices, preferably with senior-level experience at leading companies Strong problem-solving skills and advanced knowledge in product R&D;, manufacturing, quality, regulatory, and supply chain processes Proven track record in reducing time from concept to launch within medical devices Understanding of ISO 13485, EU MDR, FDA, and other relevant general regulations and standards
📌 Technical Portfolio Manager — Cmf Standard (Cataluña)
🏢 Materialise
📍 Cataluña