Sr. Principal Engineer - Product Reliability Engineering (DDCS)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of creating, developing, launching, and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to deliver platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages alliances in design and manufacturing to rapidly convert proprietary concepts into products that meet the users' needs and intended uses.

DDCS is seeking a Sr Principal Engineer - Product Reliability Engineering to support new product development along with tracking and trending the performance of legacy products for medical devices and combination products. As a key member of the development team, you will develop and implement innovative reliability approaches and analysis to deliver a world class failure-free product.

Responsibilities:

Leadership and Functional Strategy:

• Lead, mentor, and coach Lilly's DDCS reliability engineering team co-located in the US and Bangalore, India
• Apply technical expertise and utilize the latest engineering tools/technologies to ensure overall technical soundness and compliance status of the product reliability programs and processes in DDCS
• Drive continuous improvement of processes and procedures related to product reliability analysis and testing, including establishment of acceptable risk and failure rate targets and adapting and applying reliability principles to our expanding device portfolio and technologies

Delivery System Commercialization and Portfolio Delivery:

• Integrate with cross-functional medical device and combination product teams (including suppliers and development partners) to enhance product reliability and quality. Support and coordinate efforts to establish product reliability goals and to plan, execute, and monitor activities aimed at achieving those goals
• Develop product reliability specifications, test plans, and test reports to enable timely project delivery
• Provide test data analysis and interpret results for critical reliability decision-making
• Collaborate with engineering team to develop mitigations for reliability issues discovered
• Facilitate and generate FMEA and FTA (in addition to other risk management tools) for new product development
• Develop a protocol and assist in implementing a FRACAS system to record, track and trend detailed observations of field failures and failures during development testing. Integrate CAPA into newly developed FRACAS system
• Develop necessary criteria and database configurations to use statistical methods for data analysis to predict product reliability

Basic Requirements:

• B.S. in Engineering (Mechanical, Electrical, Industrial, or Reliability)
• 7+ years of employment history that includes experience in Reliability Engineering and Testing

Additional Skills/Preferences:

• Strong statistical background
• M.S. in Engineering (Mechanical, Electrical, Industrial, or Reliability) and additional experience is preferred
• Knowledge of reliability fundamentals and analysis as applied to product design (life predictions, product life modeling, root cause analysis, environmental testing, accelerated testing, etc.)
• Experience using ReliaSoft's Synthesis platform tools or other reliability analysis software is preferred
• Professional reliability certification is desirable
• Excellent communication and technical writing skills

Additional Information:

• Estimated travel of up to 10% both domestic and international

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