- Support the development of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 62304 and other regulatory standards.
- Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- Interact and form constructive working relationships with all levels of leadership within Quality, Product Managers, R&D, and Operations.
- Represent the quality engineering function as part of a cross functional team in new product and process development
- Collaborates with cross-functional project team members as well as members of the QA extended team.
- Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
- Ensure completeness of project documentation (e.g., DHF).
- Ensure all tasks are conducted in accordance with applicable regulatory standards and standard operating procedures
- Minimum Experience: 2-5 years of experience in regulated industry within the Quality, Testing or R&D Engineering function.
- Proven ability to directly lead and/or co-lead multiple tasks and projects.
- Strong understanding of industry expectations in the areas such as voice of customer, software development, requirements analysis, risk management, software testing levels, software reliability, etc.
- Experience with Requirements Management tools, configuration management tools, and defect tracking tools.
- Ability to work with distributed and international teams.
- Strong collaboration, negotiating, and conflict resolution skills.
- Fluid verbal and written communication skills.
- ASQ Certified Quality Engineering (CQE)
- Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
- Coaching and mentoring skills
Nutrino is an innovator in the field of artificial intelligence, data analytics, MLOps and cloud computing. As part of the Medtronic family, we are focused on exciting innovation in medical technology research and the infrastructure powering the company’s future product pipeline. We are looking for bright, hard-working, and creative thinkers to join us in our journey.We are a Tel-Aviv based company, with a start-up spirit and corporate backing. Our team is enthusiastic and eager to apply cutting-edge technologies and methods to revolutionize the world of data enabled therapy and improve the quality of life of people around the world. Let’s work together at the interface of tech and health and transform our vision into reality.
Join us in shaping the future.