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Senior Sustaining Engineer Req ID: 52893 Job Category: Engineering Location: Mentor, OH, US, 44060 Workplace Type: Hybrid At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The Senior Sustaining Engineer is responsible for all design aspects of our products after a product is released for production. Responsibilities include design and design control for product changes that result from supplier changes, quality improvements, new or changing regulations and standards, performance improvements, and cost reductions. Projects must be completed accurately, within compliance, and quickly to avoid stock-outs. The position should also actively seek areas for improvement in internal processes and create innovative solutions in both product design and process flow. The engineer is responsible for assisting in CAPAS, NCR's, and complaint investigations. What You'll do as a Senior Sustaining Engineer Work within cross-functional team structure to ensure projects maintain momentum, meet timelines, and collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, and intellectual property. Responsible for product design including CAD design, prototyping, and design control documentation including input/output specifications and risk management files. Engineer is responsible for writing product verification and validation protocols and leading various teams in product risk assessments (hFMEA); maintain design history file documents in accordance with the Quality Management System Work independently or with other engineers as well as clinicians and marketing representatives to review design ideas and prototypes; proactively coordinate, direct, and perform design activities related to GI endoscopic devices and accessories that were previously released for manufacturing. Ability to determine engineering related design control requirements when assigned a project/problem with regards to a currently marketed device. Understands project risks and develops plans and contingencies to mitigate failures. Effectively manages multiple projects and/or responsibilities concurrently, while adapting to changing needs and priorities. Prioritizes tasks appropriately and delivers on project deliverables and milestones. Maintains a sense of urgency. Work with NPD teams to ensure smooth Design Transfer of New Products into production Work with multiple different groups of people to ensure minimal risk to the production floor (including stock-outs) when introducing a change. Demonstrates technical knowledge in areas such as materials, plastics, molding, welding, component assembly, and packaging, and effectively utilizes knowledge to design and support the technical needs of the organization. Communicates clearly and effectively, especially regarding key changes to project scope, quality, timeline, and expenses. Presents project updates to technical and non-technical audiences effectively (meetings, presentations, etc.). Actively seeks areas for improvement in internal processes and creates innovative solutions in both product design and process flow. Leads or assists with resolution and mitigation of CAPAS, NCR's, and complaints. Mentors team members on timely task completion and guides others in decision-making and breaking down complex tasks. Generates detailed, high quality technical documentation to capture and communicate designs. The Experience, Abilities and Skills Needed Bachelor's Degree in Engineering and 5 + years of experience 5+ years of experience in Design control,