Senior R&D Engineer

Job Responsibilities Sr. R & D Engineer is needed to perform the following duties: Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling). Quality initiatives and compliance when participating and Design and Phase reviews. Ensure the use of statistically valid sampling techniques and teach others on the use of these and other advanced statistical techniques such as DOE and ANOVA evaluations. Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria. Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Provide support for CAPA/NCRs/Complaints. Assists with special projects as needed. Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities. Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation. Communicate with internal/external customers and vendors; represent work through internal conferences and collaborations across multiple business units and functions. Serve as an effective leader and team member in supporting quality disciplines, decisions, and practices. #J-18808-Ljbffr