Senior R
3 weeks ago
Duties and Responsibilities: Lead the design and development of new products from concept to successful market launch through cross functional collaboration and in accordance with FDA and international regulations.
- Lead cross-functional project teams to the successful completion of project goals. Work includes ensuring scope of work, costs, schedules, and risks are properly planned, resourced, and managed.
- Establish design goals and specifications based on requirements and user needs.
- Interact with physicians to transform clinical observations into new device concepts or approaches.
- Monitor progress, provide project updates on a consistent basis and report out and up project progress and status.
- Support the team with all project activities, overview technical challenges, thoroughly analyze problems, identify potential solutions and their ultimate impact on the project and business.
- Design, build and test functional prototypes to demonstrate proof of concept in bench testing and animal studies.
- Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. Must be willing to travel to vendors for various activities.
- Develop and perform design verification and validation activities. Generate test protocols and test reports.
- Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485
- Mentor junior engineers and technicians.
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