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 NPI manager will lead and manage a variety of tasks to transfer products from design to manufacturing. This high-impact role requires a professional with deep knowledge in development and manufacturing processes, excels in learning on the fly, can switch between planning, analyzing, supporting, and managing multiple tasks and teams; all while collaborating with cross-functional teams both internally and externally. The successful candidate will be highly motivated, exceptionally independent, a decision maker person, full with passion to execute complex operations tasks, including: product V&V, small and large scale manufacturing, control of supply chain and managing the company’s inventory and warehouse. The position may require some overseas traveling (depending on the COVID-19 pandemic restrictions).
Responsibilities:
• Plan and execute tasks, for shifting the product from design verification (DV) to a CE mark and FDA approved product in a medium scale manufacturing setup.
• Operate a pilot, small scale, manufacturing setup in house, and issue all required documents to transfer the manufacturing process to a larger facility. Managing all the design outputs, warehouse, approve new suppliers, control incoming goods, plan the assembly process and oversee QC inspections; using SAP business 1 platform (ERP).
• Identify, control and mitigate the risks involved in the design transfer and assembly process
• Document the design transfer process, in collaboration with QA manager, and will be representing the company during external and internal audits.
Requirements
• Proven experience in leading the production / assembly of a medical device (IVD advantage) from design verification (DV) to process validation (PV).
• Expert in new product introduction (NPI) and first series product testing and validation.
• An engineering degree or other relevant academic education (Process Engineering is a major advantage).
• Experience in resource and budget management.
• Experience in working in a regulated environment (e.g. ISO 13485, ISO9001 or GMP).
• Demonstrated experience in performing Risk Analysis, updating the Risk Management File and / or perform Process Risk Analysis / FMEA - advantage .
• The Position requires traveling overseas to suppliers and development groups.
• Excellent English and Hebrew, both speaking and writing
• Full proficiency in MS office / Google drive and any type of ERP 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