We are seeking an experienced and visionary Director of Smart Medical Technologies to lead the design, development, and implementation of innovative connected medical device solutions.
In this leadership role, you will drive strategic decision-making, ensure compliance with industry standards, and deliver impactful solutions that meet the needs of pharmaceutical and drug-device combination products.
You will collaborate with cross-functional teams to integrate connected technologies into commercial products while overseeing risk assessments and mitigation strategies.
Key Responsibilities: Technology Scouting: Stay ahead of emerging trends and technologies in the connected medical device space, evaluating and incorporating suitable options into R&D and portfolio strategies.
Lifecycle Management: Manage the lifecycle of commercial products containing connected technologies, ensuring they meet safety, performance, and regulatory standards.
Prototype Development & Testing: Oversee the creation of prototypes and ensure rigorous validation processes to ensure the safety and efficacy of connected technologies.
Cross-Functional Collaboration: Work closely with senior leadership, core device platform teams, manufacturing sites, Digital, Global Quality, GRA, and other key M&S functions.
Risk Management: Lead risk assessments related to device functionality and design, and implement effective risk mitigation strategies as needed.
Qualifications: Experience: 10–12 years of experience in digital medical device technologies and software development, as well as a strong understanding of regulatory and quality requirements.
Technical Expertise: In-depth knowledge of FDA 21 CFR 820.30 Design Controls, ISO 13485, and ISO 14971 Risk Management guidelines.
Leadership Skills: Proven experience leading cross-functional teams, with strong interpersonal and influence management abilities.
Industry Insight: Experience with the development of connected medical devices, preferably within the pharmaceutical and drug/device combination product industries.
Position: Director of Smart Medical Technologies Contract: Permanent Start Date: By agreement #J-18808-Ljbffr