Our company develops, manufactures and markets unique in-vitro diagnostic solutions for a rapid detection of infectious agents, specially designed for small to mid-sized laboratories, doctor offices and mobile care units. The product is a cutting-edge molecular diagnostics platform that will revolutionize the way laboratories test infectious diseases. We are a team of professionals, on a mission to bring the best solution to the market, working in a fast paced and collaborative environment
About the position
The R&D Project Manager (PM) will lead and manage a variety of product development and product realization tasks on behalf of the company, in a multidisciplinary manner. This high-impact role requires an 'A player' proffesional, who excels in product development from early conceptual stages to product realization. The PM should be able to control, analyse, support, and manage multiple tasks and subcontractors, while collaborating with cross-functional teams both internally and externally. The successful PM will be highly motivated, super independent, a decision maker, engaged in a fast-paced work environment and demonstrate ability to work effectively in a small team setting. The position requires some overseas traveling; depending on the COVID-19 pandemic restrictions.
Responsibilities:
• Plan and execute all product development tasks including mechanical, electronic and biological aspects of the product
• Manage internal and external development teams from early conceptual stages to fda/ce approval.
• Define, prioritize and execute project plans, set the schedules, define tasks, milestones and prioritize them, manage budgets, approve new suppliers, come up with creative solutions and report on the deliverables.
• Serve as liaison and central point of contact for suppliers, engineers, vendors, company management, quality manager, and operations; building credibility, promoting transparency and managing expectations.
• Review and analyse complex, integrated project data and information to provide status updates, insights, conclusions and actionable recommendations.
• Identifying project risks and clearly communicating them with the company management. Advise the product team members on decisions regarding deliverables that are critical to the success of the project and prioritize them accordingly. Control the design history file (DHF) of the product.
Requirements
• Proven experience in leading development of a medical device (IVD advantage) from early characterization to FDA/CE approval
• Expert in leading medical device product design, testing and verification.
• Relevant academic degree in the fields of engineering/ biotechnology or other related scientific field.
• Experience in managing sub-contractors
• Experience in budget management.
• Project management experience in highly regulated industry (such as ISO 13485 or 9001).
• Demonstrated experience in performing Risk Analysis, control of Risk Management File and / or perform FMEA - advantage.
• The Position requires traveling to suppliers and development groups overseas.
• Excellent English and Hebrew, both speaking and writing
• Full proficiency in MS office / Google drive and any type of project management tool.
This is a full-time position.
Location: Tel Aviv until mid 2021. Rehovot-Ashdod from mid 2021 (partial working from home flexibility)
Please send you CV with the Job title and number to: Alumni@weizmann.ac.il