Senior Design Assurance Engineer

Bachelor's degree in engineering (or other related technical discipline). 5+ years of experience in design assurance, post-market quality, or R&D engineering. Strong mechanical and electrical aptitude. Experience writing specifications, test protocols, and technical reports. Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why's. Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics. Experience with mechanical and electrical test and measurement equipment. Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise. Proficient use of Microsoft Teams, Word, PowerPoint, and Excel Bachelor's degree in mechanical engineering. Experience in design engineering or process development, including test method validation, process validation, and continuation engineering. Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA). Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD). Adaptable and effective collaborator in a team environment or in self-directed work.