Job Description
*Process Engineer – Indy Device Manufacturing (IDM)*
*Location:* Indianapolis, Indiana
*Duration: *Contract to Hire
*Position Summary*
The *Process Engineer* plays a key role in the development, delivery, qualification, and optimization of custom automated assembly equipment for IDM globally. This position collaborates closely with internal teams and Original Equipment Manufacturers (OEMs) to ensure that equipment meets technical, quality, and regulatory requirements. In addition, the engineer may support the installed base of equipment at Lilly and CMO sites when needed.
*Key Responsibilities*
* *Technical Proposal Assessment:* Evaluate OEM proposals for technical feasibility and alignment with project needs.
* *User Requirements:* Develop and validate user requirements and test plans.
* *Risk Management:* Conduct and manage pFMEA activities to identify and mitigate technical and patient risks.
* *Design Reviews:* Lead detailed design review sessions with OEMs and project stakeholders.
* *Documentation:* Verify OEM documentation is accurate, complete, and compliant with specifications and standards.
* *Engineering Studies:*
* Define key control parameters.
* Create engineering studies protocols and reports using statistical methods (DOE, GR&R).
* *Change Management:* Maintain detailed records of project changes, adhering to formal procedures.
* *Site Readiness:* Collaborate with receiving sites to ensure equipment is fully production-ready.
* *Safety & Compliance:*
* Identify and document potential HSE risks.
* Participate in safety walkdowns and ensure compliance with safety standards.
* *Maintenance Planning:* Partner with OEMs and sites to develop equipment maintenance plans.
* *Performance Optimization:* Identify and implement opportunities for equipment improvement.
* *Design Checklist:* Assist in developing and maintaining the Design Consideration Verification Checklist.
*Basic Qualifications*
* Bachelor's degree in Engineering (Electrical, Mechanical, Chemical, or Biomedical preferred)
* Minimum 2 years of engineering experience, preferably in:
* Medical device or pharmaceutical manufacturing
* High-speed assembly or packaging equipment
* Capital project delivery
*Preferred Qualifications*
* Experience with automated manufacturing systems
* Familiarity with regulated environments (cGMP, Commissioning & Qualification)
* Experience managing large capital projects or leading sub-projects
* Knowledge of DOE, GR&R, and statistical analysis methods
* Exposure to vision systems for inspection/debugging in assembly processes
* Experience in medical device manufacturing is a strong plus
*Skills & Attributes*
* Strong initiative, accountability, and ownership
* Effective communicator with strong teamwork and networking skills
* Excellent technical writing and documentation skills
* Organized, detail-oriented, and capable of managing multiple priorities
* Analytical problem solver
* Able to work independently or lead within cross-functional teams
* Skilled at building relationships and influencing across teams and functions
*Additional Information*
* *Travel Requirement:* Average 25%, with occasional peaks over 50% during critical phases of project execution.
_Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws._
Job Type: Contract
Pay: $65.00 - $75.00 per hour
Expected hours: 40 per week
Benefits:
* Dental insurance
* Health insurance
* Vision insurance
Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
Ability to Commute:
* Indianapolis, IN 46266 (Required)
Ability to Relocate:
* Indianapolis, IN 46266: Relocate before starting work (Required)
Work Location: In person
Job Tags
Hourly pay, Contract work, Local area, Relocation, Shift work, Day shift, Monday to Friday,