You are responsible for
- Manage and monitor budgets of resources, tools and training.
- Conduct resources portfolio management and allocate team members to programs / Sprint teams
- Ensures compliance with product lifecycle development procedures and processes as well as all applicable medical devices quality and regulatory requirements globally
- Oversee program requirements and risk management life cycle management
- Development of requirements and risk management infrastructure and tools
- Serve as a mentor and coach teams to make appropriate system and component design decisions during the different phases of product development
- Ensure appropriate personnel management practices regarding recruitment and selection, adequate resource allocation / resource portfolio management, remuneration, performance appraisals, people development and change management
- Responsible for program deliverables of the System Team within the SAFe Train (systems engineering and SW QA)
- Drives for a consolidated product architecture creating well-defined building blocks / system options & scenarios
- Guide and coach the SW QA team in developing test plans procedures, and execution together with the SW QA manager
- Lead and promote common procedures and ways of working across the Radiation Oncology business
- Identify process improvement opportunities and promote compliance while maintaining a lean approach to execution
You are a part of
The Radiation Therapy Planning Business within the global Radiation Oncology Solutions business. The Radiation Oncology business is part of the Oncology Solution business. The Therapy Planning business is a software and solutions business. Our Radiation Therapy planning solutions provide state of the art capabilities serving clinicians across the world.
To succeed in this role, you should have the following skills and experience
- BS or MS in relevant field including Computer, Electrical, Systems Engineering, or other related science.
- Minimum 10 years of experience with Systems Engineering including design, process and documentation
- Minimum 7 years of experience as a Systems Engineering manager in a global organization
- Strong understanding of medical device regulatory environments and clearance processes.Demonstrated experience and leadership using Agile/SAFE framework and standard Lean Instruments to drive continuous improvement.
- Demonstrated depth in organizational dynamics, motivating teams, and developing talent.
- Expertise in all phases of product development, launch, and maintenance including VOC, requirements generation, DFx, design controls, verification, validation, usability, process validation, manufacturing ramp, service, and support-readiness.
- Desired: An understanding and practical experience of Radiation Therapy planning and Radiation Oncology.