Senior Development Engineer
STERIS - mentor, OH
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Job Title: Senior Development Engineer Req ID: 44889 Job Category: Engineering Mentor, OH, US, 44060 Description: 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 STERIS Procedural GI business unit is seeking a motivated, intelligent, curious, and driven engineer for an open Senior Development Engineer position to help drive collaborative innovation and product launches for the Therapeutic Value Stream. Development Engineers at STERIS Endoscopy are responsible for the development and release of innovative products to better diagnose, prevent, and treat disease of the gastrointestinal tract. You will work closely with Design Engineers, Project Management, Cross-Functional Teams, Clinicians, Physicians, vendors, and external resources to turn user needs into viable solutions. Development Engineers are responsible for facilitating design and development of products, design controls, risk management, product qualification, product clearance, and product release. Duties Develop GI endoscopic medical devices from concept development to full market release by working within a cross-functional team structure to ensure that the assigned project meets user needs, engineering deadlines and budgets. Ensure that collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, intellectual property, and strategic fit within the product portfolio. Work closely with the Project Manager by discussing project planning, key project decisions, user needs and product requirements, and providing updates on key engineering tasks, technical risks and engineering milestones. Provide engineering updates to the CFT in a clear and concise manner. Support the Design Engineer by helping to identify and communicate product requirements, potential design options, and timing goals for key engineering activities. Work with the design engineer to implement best practices that help reduce technical risks and meet timeline goals. Work with the Design Engineer to create an engineering plan for the project that will meet the timeline of the overall project schedule. Work with a cross-functional team to identify user needs and project requirements and then translate those into design specifications. Integrate input from various sources such as clinical, quality, engineering, manufacturing, and marketing disciplines. Interpret and evaluate data from engineering research and/or marketing investigations to determine the performance requirements that will be incorporated into the product. Observe device/prototype performance in lab or initial market release for future verification and validation requirements. Work with the project manager, marketing, clinicians, and design engineers to obtain feedback on design ideas and prototypes. Responsible for product development documentation such as 510(k) testing protocol and report, sterilization testing or adoption, biocompatibility testing protocols and reports, and engineering reports documenting key decisions and rationale, etc.. Work closely with the Design Engineer to support all Intellectual Property activities such as documenting design ideas in an IP Assessment, confirming freedom to operate, reviewing patent filings, and discussing patents with internal or external patent attorneys. Must be able to present project updates to technical and non-technical audiences (project meetings, board meetings, etc.) This position may be required to solely represent the engineering function in key meetings. Identify areas for improvement in internal processes and create solutions. Help to cre
Created: 2024-10-16