IDM Asset Delivery Process Engineer

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 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.

Indy Device Manufacturing (IDM) is an external-facing team responsible for manufacturing medical devices and delivering custom assembly equipment used as part of the manufacturing process. These equipment deliveries support new product launches, capacity expansions and line extensions for IDM at Lilly sites and Contract Manufacturing receiving sites across the globe.  

IDM Asset Delivery Process Engineers are responsible for providing technical support for developing, designing, qualifying/validating and delivering automated device assembly equipment for IDM globally to both Lilly sites and Contract Manufacturers. In addition, when primary support teams for the global installed base (CMO and Lilly sites) require assistance, these engineers provide technical support in returning lines to service or optimizing lines. 

This role works closely with other IDM team members and the Original Equipment Manufacturers (OEM) to design and build custom medical device assembly machines.

Key Objectives/ Deliverables:  

The Process Engineer is responsible for the following tasks related to the automated device assembly equipment design, delivery, and qualification/validation.                          

Responsibilities:

• Technical Proposal Assessment: Assess technical proposals from original equipment manufacturers (OEM)
• User Requirements: Generate user requirements for each project asset
• pFMEA Develop: Manage to identify and mitigate technical and patient risks
• Design Reviews: Conduct detailed review sessions with OEMs and project teams to ensure design aligns with all requirements and conforms to local/corporate standards
• OEM Design Documentation: Verify documentation is comprehensive, complete and accurately represents the specifications of the equipment
• Key Control Parameters: establish through the Engineering Studies Plan
• Engineering Studies Protocol: Develop and implement summarized protocols in reports for verification testing
• User Requirements: Develop and perform testing to verify
• Performance Improvements: Identify opportunities to optimize equipment
• Safety Risks: Assess, document and engage in HSE walkdowns
• Maintenance Plan: Work with OEM and local site to develop the plan
• Engineering Tools: Utilize Design of Experiments (DOE), Gauge Repeatability & Reproducibility (GR&R), and statistical methods for conducting engineering studies and preparing reports.
• Change Management: Document all project changes and adhere to formal change management procedures
• Receiving Site Collaboration: ensure equipment is production ready
• Design Consideration Verification Checklist: Assist in developing the checklist

Basic Requirements:

• BS in an Engineering (Electrical, Mechanical, Chemical, or Biomedical Eng preferred)
• Minimum 2 years engineering experience, preferably in medical device, pharmaceutical, or related industry working with high speed, discrete mechanical/process assembly & packaging equipment
• Experience in capital project delivery

Additional Preferences:

• Medical Devices experiences preferred
• Experience working with automated manufacturing equipment
• Engineering in regulated pharmaceutical environments (cGMPs/Commissioning and Qualification)
• Large capital project delivery and sub-project management
• DOE and statistical methods in engineering
• Experience with vision systems for part inspection and debugging of assembly equipment
• Eager to support and lead team efforts while learning

Skills:

• High initiative, ownership, and accountability
• Strong communication, teamwork, and networking
• Solid technical writing
• Organization and prioritization of multiple tasks
• Attention to detail
• Problem-solving
• Ability to work independently and in teams
• Ability to lead and influence across organizational and company boundaries
• Ability to form and foster relationships with others not in your organization

Additional Information:

Ability to travel 25% on average, with peaks over 50% for a few months