Associate Consultant Engineer

Mô tả công việc

A Delivery Devices, Research and Development (DDR&D) Design Engineering is a key role supporting DDR&D’s mission to “Simplifying Patients Lives”. Specifically, this role is a design engineer responsible for ensuring the integrity of robust device designs, through providing mechanical design expertise for Drug Delivery Device Research and Development (DDR&D), which includes the support of device projects in either the early-stage or full-scale development. This individual will interface with project engineers and project teams, design partners and engineering firms involved in the design of devices.Key Objectives/Deliverables: Provide design engineering technical expertiseEnsuring the robustness of device designs, in the following areas:Intellectual Property support: support the Legal team by providing detailed technical expertise for ongoing Lilly device intellectual property (started under Advanced Development); Technical Merit: ensure that device design concepts are based on sound design engineering principles; Technical Rigor: ensure that device design resources utilize appropriate engineering analysis tools on their projects; Design and Moldability expertise: ensure that the designs are appropriate for injection molding, metal stamping, die-casting (other manufacturing processes); manual and/or high-speed assembly.Management Updates: responsible to provide design-related opinions to support the integrity of device projects for internal Senior Management. Coordinate Device Risk Assessment and Design Control Deliverables(including ensuring the completion of required Phase documentation and Phase closure)Provide Design Expertise "Mentoring" to other Engineers across the design platform.Design Validation and Verification activities experience with the device quality system regulation: Drawing and part specification development and review. Writing technical reports, work instructions, change control documentation and development plans. Management of third party relationship and drive key technical deliverables Expertise in general project management skills, and a familiarity with the major steps required in technical product development, especially in a regulated environment Able to lead multi-functional I multi-site project teams consisting of members of production, planning, quality control, marketing, as well as external design and manufacturing. Conduct meetings and prepare design-specific project presentations and reports, in addition to publishing basic schedules and participating in project problem-solving. Experience in Product Development, Commercialization and Product Launch: Experience in product development including early stage product selection, an understanding of customer needs, and knowledge of industry trends, through maintaining contacts in device community. Exposure and familiarity with validation and scale-up requirements.Evaluation or creation of finite element analysis, tolerance stacks, mold flows, DOE, FMEA's. Experience in DFx (manufacturing, reliability, assembly, ultrasonic welding parameters, gluing, snap fits) Must be able to understand device technical issues at a deep level (testing anomalies and failures) and develop actions plans to address them. Engage with Contract Developers and Manufacturers to efficiently drive collaboration on development projects. Partner with manufacturing and Quality to ensure robust design, testing, and Design Control deliverables. Partner with Business Unit representatives (primarily Medical and Marketing) on Patient Centered Design. Build strong relationships (internally and externally) quickly and maintain them over time.Understand design control, risk management, control strategy development and apply these principles to product & process designs.