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Automation Engineer-Device Manufacturing

2 months ago

Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Details

At BioSpace, Inc., we unite innovation with expertise to make a difference in the world. We are a global leader in the healthcare industry, 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 a difference in the world.

Position Brand Description:

Indy Device Manufacturing (IDM) is an external facing team responsible for the manufacturing of medical devices and the delivery of the custom assembly equipment utilized as part of the manufacturing process.

Automation engineers oversee the technical aspects of developing, designing, constructing, and delivering automated device assembly lines for IDM globally to both Lilly sites and Contract Manufacturers in support of new product launches, capacity expansions, and line extensions.

Automation engineers in IDM work closely with Original Equipment Manufacturers (OEM) to design and build custom medical device assembly machines.

These engineers also develop and implement best practices for design and startup of device assembly lines and deploy systems to capture and utilize process data.

Key Objectives/Deliverables:
  1. Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability
  2. 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.
  3. Manage the generation rationalization of user requirements for each project
  4. Define and mitigate technical and patient risks, including use of FMEA
  5. Assure each design includes maximum appropriate re-use of technology from prior projects
  6. Oversee OEM's design process, assuring questions are resolved and barriers to progress are removed
  7. Conduct thorough design reviews to assure design meets requirements and local/corporate standards
  8. Characterize unit operations and set operating conditions as required by defining an Engineering Studies plan, developing rigorous studies and executing them
  9. Assure testing is appropriately developed and is in accordance with the risk level of the item being tested
  10. Document research and investigations as technical reports
  11. 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.

  12. Work with external companies and project teams to develop product and process improvements.
  13. 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.
  14. Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
  15. Participate on Commercialization project teams for new devices with focus on manufacturing readiness.
  16. Lead cross-functional/cross-site/cross-company project teams as needed.
  17. Identify and implement process and product changes necessary to maintain, sustain and improve the manufacturing process.
  18. Support Technical Stewardship projects to improve device design.
Minimum Requirements:
  • BS in an Engineering or Engineering related field
  • Minimum 2 years engineering experience, preferably in Manufacturing
Additional Preferences:
  • Medical Devices experiences preferred
  • Experience with DOE and statistical methods as applied to engineering studies and reports
  • Experience in large capital project delivery and management of sub-projects within a larger project
  • Demonstrated high degree of ownership / accountability
  • Experience with engineering in a regulated pharmaceutical environment/cGMPs/Commissioning and Qualification
  • Experience in programming control systems for high-speed assembly lines
  • Strong communication, teamwork, and networking skills
  • Expertise in automation networks, vision systems for part inspection, debugging of assembly lines
  • Solid technical writing skills
  • Proven ability to organize and prioritize multiple tasks
  • Strong attention to detail
  • Proven problem solving skills
  • Ability to work independently as well as in a team environment
Other Information:

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

BioSpace, Inc., Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.

If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources (

) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

BioSpace, Inc. is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position at BioSpace, Inc., please complete the accommodation request form (

) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

BioSpace, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles

Our current groups include:

Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.

Learn more about all of our groups.

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