Engineering Advisor
Eli Lilly - Indianapolis, IN

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Job Description: ResponsibilitiesThis role is the senior design and process engineering lead responsible for ensuring the integrity of robust device designs, through providing mechanical/electrical design expertise for all Delivery Device Research and Development (DDR&D), which includes the support of device projects in both the early-stage Advanced Development area, as well as subsequent, full-scale development that occurs in the Commercialization area. This individual will be directly responsible for the design and process engineers as well as interface with Development project managers, project teams, manufacturing leads, primary and secondary packaging, formulation scientists, design partners, and engineering firms involved in the design of Lilly devices.The Delivery Devices, Research and Development (DDR&D) Design and Process Engineering Lead is a key role supporting DDR&Ds mission to Simplifying Patients Lives'.Candidates must possess a history of strong leadership, deep practical engineering knowledge and a proven track record for timely project delivery, project management, cost control and customer satisfaction. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results and follow established fundamental processes. Key Responsibilities: Lead a team of design and process engineers: Manage a team of design engineers to ensure they have the technical depth necessary to bring patient centered design to fruition. Assess the current design and process tools / techniques being employed and improve the processes as necessary. Assess projects for design and process risks and use resources to mitigate those risks before they impact the project delivery timeline. Manage multiple projects with significant complexity (e.g. external partners, multiple locations, difficulty of electromechanical design and/or container, drug, device interface). Challenge current default practices and conventional wisdom and present effective or efficient alternatives for handling tasks in own primary areas of responsibility. Provide design and process technical expertise: ensuring the robustness of device designs, in the following areas: Intellectual Property support: support Lilly Legal by providing detailed technical expertise for ongoing support for Lilly device intellectual property (started under Advanced Development); Technical Merit: ensure that device design concepts are based on sound design principles; Technical Rigor: ensure that device design resources utilize appropriate engineering analysis tools on their projects; Must be able to understand device technical issues at a deep level (testing anomalies and failures) and develop actions plans to address them. Must be able to direct technical assessments with rigor and best practices utilizing Six Sigma skills and/or statistics. DFM / DFA expertise: ensure that the designs being developed are appropriate in their readiness for injection molding, metal stamping, die-casting (other manufacturing processes); manual and/or high-speed assembly Management Updates: as required, this individual is responsible to provide design-related opinions to support the integrity of device projects for internal Senior Management for DDR&D projects. Appropriate Risk Assessment and Design Control Deliverables : This individual is responsible for: Ensuring his team members have the ability to conduct thorough technical, project and business risk assessments for all projects; Ensuring appropriate formal approval of required risk assessment is accomplished, and; Ensuring all design or process specific deliverables are completed and documented to facilitate timely product launches. Project Management Expertise: This position requires a level of expertise in general project management skills, and a familiarity with the major steps required in technical product development, especially in a regulated environment The individual must be able to lead/influence multi-functional / multi-site project teams consisting of members of production, planning, quality control, and marketing, as well as external design and manufacturing resources. The individual will conduct meetings and prepare design-specific project presentations and reports, in addition to 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 PhD (Medical or Biomedical)
Basic Qualifications BS/MS Engineering (Mechanical Engineering preferred) 10-15 Years Device, Aeronautical, Automotive or Consumer product design experience 5 years of experience leading mechanical teams and/or projects 5+ years hands-on experience with Pro-E Additional Skills/Preferences Previous pharmaceutical and/or medical device design experience Demonstrated ability to drive technical issue resolution/improvements Strong understanding of medical device and/or pharmaceutical validation, regulatory requirements and risk management systems Strong analytical skills including statistics, DOE, and experimental design. Six Sigma Strong technical writing skills required, as well as good verbal communication skills. Additional Information: ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in...