In this role, you will need to collaborate with other team members, departments and major divisions of the company to successfully develop and implement new designs that help maintain the companys reputation for industry leading products and services.
In this role, you will work with engineers and other cross functional teams like Product Management, Project Management, Release Engineering, Quality Assurance, Operations teams etc. to develop innovative solutions that meet market needs with respect to functionality, performance, scalability, reliability, realistic implementation schedules, and adherence to development goals and principles.
In this role, the selected candidate will develop, establish, and maintain quality engineering methodologies, systems and practices in accordance with FDA QSRs and ISO 13485 to support the production and development of disposable and durable medical device systems.
In this role, you will define regulatory certification requirements for a specific product, leads certification team in the development of the certification basis proposal with several complex elements and the final negotiation of the certification basis, including resolution of issues, with the regulators.
In this role, you will assist product development teams with activities such as design requirements, verification testing methods, reliability analysis, protocols and reports, and help ensure the team is in compliance with applicable processes and regulations.
In this role, the selected candidate will work with engineers and other cross functional teams like Product Management, Project Management, Release Engineering, Quality Assurance, Operations teams etc.