IDM Asset Delivery Process Engineer

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 64,000 - 168,000; Full time

Job summary

A leading healthcare company in Indianapolis seeks a Process Engineer to support the design and delivery of automated medical device assembly equipment. This role involves collaboration with OEMs, managing project documentation, and ensuring compliance with safety standards. Ideal candidates will have a BS in Engineering and experience in the medical device industry, with strong problem-solving and communication skills.

Benefits

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Life insurance

Employee assistance program

Qualifications

• Minimum 2 years engineering experience in medical device or related industry.
• Experience in capital project delivery.

Responsibilities

• Assess technical proposals and generate user requirements for projects.
• Conduct design reviews and manage change documentation.
• Develop testing protocols and optimize equipment performance.

Skills

Problem-solving

Strong communication

Teamwork

Attention to detail

Technical writing

Education

BS in Engineering

Job description

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)
• Minimum2 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 at a time

Lilly 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 Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) 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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$64,500 - $167,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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