Process Engineer - Indy Device Manufacturing

Role Summary

The Process Engineer works with contract manufacturers and original equipment manufacturers to support, supply, quality, and continuous process improvement of delivery devices, sub-assemblies, and components supplied to Lilly packaging and manufacturing sites. You will oversee production processes, assess OEM proposals, validate tools and processes, and lead cross-functional project teams to ensure compliant, capable, and validated operations.

Responsibilities

• Provide technical oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
• Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability
• Support all aspects of tool and process validations including computer system validation. Includes creation, execution and coordination of validation activities in partnership with Contract Manufacturers.
• Manage the generation rationalization of user requirements for each project
• Define and mitigate technical and patient risks, including use of FMEA
• Assure each design includes maximum appropriate re-use of technology from prior projects
• Oversee OEM's design process, assuring questions are resolved and barriers to progress are removed
• Conduct thorough design reviews to assure design meets requirements and local/corporate standards
• Characterize unit operations and set operating conditions as required by defining an Engineering Studies plan, developing rigorous studies and executing them
• Assure testing is appropriately developed and is in accordance with the risk level of the item being tested
• Document research and investigations as technical reports
• Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab based testing, documentation of the data and completion of technical reports.
• Work with external companies and project teams to develop product and process improvements.
• Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.
• Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
• Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
• Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
• Participate on Commercialization project teams for new devices with focus on manufacturing readiness.
• Ensure timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
• Lead prioritization of process and product changes necessary to maintain, sustain and improve the manufacturing process.
• Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
• Develop effective and productive working relationships with colleagues at CM sites.
• Lead cross-functional/cross-site/cross-company project teams as needed.
• Influence Commercialization project teams for new devices with focus on manufacturing readiness.
• Identify and implement process and product changes necessary to maintain, sustain and improve the manufacturing process.
• Support Technical Stewardship projects to improve device design.
• Develop effective and productive working relationships with colleagues at CM sites.

Qualifications

• Required: Minimum 2 years engineering experience, preferably in Manufacturing
• Required: BS in an Engineering or Engineering related field
• Required: Demonstrated high degree of ownership / accountability
• Required: Strong communication, teamwork, and networking skills
• Required: Mechanical Aptitude
• Required: Solid technical writing skills
• Required: Proven ability to organize and prioritize multiple tasks
• Required: Strong attention to detail
• Required: Proven problem solving skills
• Required: Ability to work independently as well as in a team environment
• Preferred: Medical Devices experiences preferred
• Preferred: Experience with DOE and statistical methods as applied to engineering studies and reports
• Preferred: Experience in large capital project delivery and management of sub-projects within a larger project

Education

• BS in an Engineering or Engineering related field

Additional Requirements

• Ability to travel 25% on average with peak over 50% for a few months at a time