Position Summary Fulfill design assurance role on new product development (conception to launch) and sustaining projects Lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products. Support Regulatory Affairs with creating submissions and responding to submission questions. Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering. Continued support and optimization of DA centric New Product Development deliverables and processes, accounting for cross functional system interactions.
Principal Responsibilities Participate and lead New Product Development Phase Reviews and Design Reviews. Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships. Create and support the development and validation of new test methods. Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA). Develop the strategy and manage the execution of design verification and validation. Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing. Develop, execute, and manage First Article inspections. Support regulatory approvals and responses to regulatory questions. Support Sustaining Engineering for design and process changes to commercialized product. Provide direction to design assurance engineering technicians supporting assigned projects. Review and improve Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency. Support the transfer of new product development projects from development to production. Support internal and external audits.
Education / Experience Requirements BA/BS in Engineering or physical sciences required. Five years of related experience required.
Specialized Skills / Other Requirements Ability to work independently and with minimal direction. Ability to define, organize, and manage individual and team tasks. Provide direction to extended and core team members. Effective verbal and written communication. Proficient in technical report writing and review. Interpersonal skills; working in a team and as an individual contributor. Structured and methodical problem-solving approach. Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes. Strong understanding of industry regulations such as ISO13485 and FDA QSR's.