IDM TS/MS Product Steward (R2-R3)
Eli Lilly and Company, Indianapolis, IN, United States
Responsibilities
Develop potential product and process improvements.
Design control, validation and verification activities, and manufacturing control strategy.
Develop specifications, protocols, sampling plans, engineering studies, and technical reports.
Provide support to product lifecycle management and monitoring processes.
Organize and facilitate Failure Modes, Effects Analysis (FMEA) meetings and lead multi‑functional project teams.
Lead root cause investigation team to develop and implement corrective and preventative actions.
Participate in and support CMO Joint Process Teams to meet manufacturing objectives.
Participate in Design and Manufacturability reviews.
#LI-DNI
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering field.
3 years of experience working in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment.
Minimum of 3 years of experience working with CAD software packages (Solidworks, ProE, Inventor) and GD&T drawing practices.
Minimum of 3 years driving continuous improvement of test systems and validation processes.
Minimum of 3 years leading analytical evaluations of events and deviations associated with products, test systems, and analytical methods.
Minimum of 3 years working with device platforms, including design, material of construction, manufacturing process, and quality systems.
Minimum of 3 years working with Primary Loop, Operational Excellence, and Root Cause Analysis.
Minimum of 3 years working with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820, ISO 13485, and ISO 11608.
Up to 10% domestic and international travel required.
Benefits
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.
EEO Statement
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.
Location
Job location: Indianapolis, IN.
Compensation
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $101,254.00 per year.
#J-18808-Ljbffr
Develop potential product and process improvements.
Design control, validation and verification activities, and manufacturing control strategy.
Develop specifications, protocols, sampling plans, engineering studies, and technical reports.
Provide support to product lifecycle management and monitoring processes.
Organize and facilitate Failure Modes, Effects Analysis (FMEA) meetings and lead multi‑functional project teams.
Lead root cause investigation team to develop and implement corrective and preventative actions.
Participate in and support CMO Joint Process Teams to meet manufacturing objectives.
Participate in Design and Manufacturability reviews.
#LI-DNI
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering field.
3 years of experience working in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment.
Minimum of 3 years of experience working with CAD software packages (Solidworks, ProE, Inventor) and GD&T drawing practices.
Minimum of 3 years driving continuous improvement of test systems and validation processes.
Minimum of 3 years leading analytical evaluations of events and deviations associated with products, test systems, and analytical methods.
Minimum of 3 years working with device platforms, including design, material of construction, manufacturing process, and quality systems.
Minimum of 3 years working with Primary Loop, Operational Excellence, and Root Cause Analysis.
Minimum of 3 years working with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820, ISO 13485, and ISO 11608.
Up to 10% domestic and international travel required.
Benefits
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.
EEO Statement
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.
Location
Job location: Indianapolis, IN.
Compensation
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $101,254.00 per year.
#J-18808-Ljbffr