- Lead the technical assessment of OEM technical proposals and make recommendations as to OEM suitability
- Lead the generation rationalization of user requirements for each project
- Lead the definition and mitigation of technical and patient risks, including use of FMEA
- Assure each design includes maximum appropriate re-use of technology from prior projects
- Lead the OEM's design process, assuring questions are resolved and barriers to progress are removed
- Lead detailed design reviews to assure the design meets requirements and local/corporate standards
- Lead characterization of unit operations and setting operating conditions by defining an Engineering Studies Plan, developing detailed studies and completing 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
- Find and document opportunities to optimize line performance, using the capital to generate more value
- Bachelors Degree preferred (Engineering, Mechanical, Chemical, or Biomedical Eng preferred)
- Experience dealing with design, startup, and/or operation of high-speed mechanical assembly lines
- Minimum 2 years engineering experience, preferably in manufacturing
- Experience in capital project delivery
- Demonstrated high degree of ownership / accountability
- Strong communication, teamwork, and networking skills
- Mechanical proficiency
- Solid technical writing skills
- Ability to coordinate and prioritize multiple tasks
- Strong attention to detail
- Proven problem solving skills
- Ability to work independently as well as in a team environment
- Experience with Medical Device assembly
- Experience with engineering in a regulated pharmaceutical environment/cGMPs/Commissioning and Qualification
- Experience programming control systems for high-speed assembly lines
- Ability to lead and influence across organizational and company boundaries; ability to form relationships with others not in your organization
- Experience with DOE, GR&R, Statistical methods as applied to engineering studies and reports
- Experience in large capital project delivery and management of sub-projects within a larger project
- Expertise in automation networks, vision systems for part inspection, debugging of assembly lines
- Expertise in process data historian configuration and/or use
- Ability to travel 25% on average, with peaks over 50% for a few months at a time.
Process Engineer - Indianapolis, United States - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
Indianapolis Device Manufacturing (IDM) - Asset Deliver Process Engineering provide the technical leadership in developing, designing, constructing, and delivering/upgrading automated device assembly and packaging lines for IDM globally to both Lilly sites and Contract Manufacturers (CMO).
Responsibilities:
IDM Asset Delivery Process engineers coordinate the technical aspects of developing, designing, constructing, and delivering automated device assembly and packaging lines for IDM globally to both Lilly sites and Contract Manufacturers in support of new product launches, capacity expansions, and line extensions. In doing this, they function as the Technical Lead for the project. In addition, when primary support teams for the global installed base (CMO and Lilly sites) require assistance, these engineers provide assistance or leadership in returning lines to service or optimizing lines. These engineers also develop and implement best practices for design and startup of device assembly lines and deploy systems to collect and use process data.
Basic Qualifications:
Additional Skills:
Additional Information:
Lilly 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.
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