Our Client, a leading Medical Device Manufacturer is hiring a Principal R & D Engineer. The Principal Engineer provides technical leadership, support and guidance to the R&D project teams and individuals tasked with the development of new medical device products in compliance with applicable regulations. The Principal Engineer will take technical responsibility for several projects through the entire design cycle and interface with the customer.
Responsibilities include but are not limited to the following:
In the Area of Technical Leadership
- Explore clinical areas through desktop and user focused research to identify new market opportunities
- Drive ideation teams to develop an understanding of the needs and develop new solutions
- Develop clinical network for collaborations
- Identify opportunities for collaboration and funding support with universities, government agencies etc.
- Works with patent Attorneys to understand the IP landscape and develop IP protection/FTO strategies
- Ownership of technical aspects of product development process
- Participate as a technical lead on multiple cross-functional development teams that manage design activities on project teams
- Assist in development and testing of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
- Accurately and efficiently assist with collecting and translating user and patient needs through design requirements, design specifications, and into verified/validated devices and procedures
- Resolve technical problems
- Lead product development activities to ensure efficiency, excellent product quality and the associated documentation.
- Monitor and Manage projects costs
- Oversee technical aspects of design reviews and transfers to production
In the Area of Communication
- Monitors and reports project status, risk, resources, etc in a clear and timely manner.
- Interfaces with various business units to coordinate projects and resources
- Provides technical insight and recommendations for product improvements and next generation products
- Presents innovation outputs to corporate management team for future direction
- Guides and motivates team members to get the best results for all stakeholders.
In the Laboratory and Production Area
- Manage prototyping efforts efficiently including evaluations with end users, competitor product assessments etc.
- Drive development activities through regulatory clearance and design transfer
- Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements
- Lead builds and product testing for design verification and validation with support from engineering and production