BioSpace, Inc.
Principal Systems Engineer
BioSpace, Inc., Indianapolis, Indiana, us, 46262
Job Details
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.
In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of crafting, developing, launching, and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to deliver platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages alliances in design and manufacturing to rapidly convert proprietary concepts into products that meet the users' needs and intended uses. As a Systems Engineer, you are a key member of the multi-functional team comprised of other technical disciplines (Software, Electrical, Mechanical, Materials, etc...) as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety. You will integrate all technical disciplines and functions into a team effort throughout the structured development process. Defining the requirements and architecture of the system (the "pieces" and how they interact), the performance and functional requirements of the system (what the system must be capable of doing and how well), system risk, and the integration and test (verification and validation) of the overall system are major components to this role.
Key responsibilities include the following: Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process Work with technical lead to drive consistency when developing, managing, and documenting stakeholder needs and requirement Perform, create, and manage system requirements including but not limited to requirements analysis, development, and allocation Create and manage traceability from requirements (including system risk) to system verification/validation Develop and document system architecture, including preliminary concept development trades-offs and system functional analysis Identify system hazards and perform system risk identification, assessment, and management Develop and document the system test strategy and lead system integration, verification, and validation activities Participate in the internal systems engineering community of practice to keep abreast of relevant systems engineering tools and techniques (literature / technologies / capabilities / regulatory) to optimize project, team, and individual performance Drive continuous process improvement, with a specific focus on systems engineering related processes. Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately. Basic Qualifications
Bachelor's degree in a Science, Technology, Engineering, or Math (STEM) field Experience in Systems Engineering in a regulated industry Additional Skills & Preferences
Demonstrated ability to lead multi-functional teams, work effectively across boundaries, and to effectively influence without authority Strong collaboration skills and ability to work productively in an interdisciplinary environment Broad, integrated technical knowledge for system and design engineering, product development, and commercialization in a highly regulated environment Excellent written and verbal communication skills, able to effectively interact at all levels of the organization - business leaders, senior technical/scientific personnel, internal/external customers/suppliers/teammates Previous systems engineering experience, which includes creating systems engineering work products and integrating complex, multi-disciplinary systems utilizing industry standard SE tools and techniques, including model based systems engineering (MBSE) INCOSE certified Systems Engineering Professional (ASEP, CSEP, ESEP) Knowledge of ISO 14971 Experience with Design Control
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 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.
#WeAreLilly
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.
In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of crafting, developing, launching, and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to deliver platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages alliances in design and manufacturing to rapidly convert proprietary concepts into products that meet the users' needs and intended uses. As a Systems Engineer, you are a key member of the multi-functional team comprised of other technical disciplines (Software, Electrical, Mechanical, Materials, etc...) as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety. You will integrate all technical disciplines and functions into a team effort throughout the structured development process. Defining the requirements and architecture of the system (the "pieces" and how they interact), the performance and functional requirements of the system (what the system must be capable of doing and how well), system risk, and the integration and test (verification and validation) of the overall system are major components to this role.
Key responsibilities include the following: Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process Work with technical lead to drive consistency when developing, managing, and documenting stakeholder needs and requirement Perform, create, and manage system requirements including but not limited to requirements analysis, development, and allocation Create and manage traceability from requirements (including system risk) to system verification/validation Develop and document system architecture, including preliminary concept development trades-offs and system functional analysis Identify system hazards and perform system risk identification, assessment, and management Develop and document the system test strategy and lead system integration, verification, and validation activities Participate in the internal systems engineering community of practice to keep abreast of relevant systems engineering tools and techniques (literature / technologies / capabilities / regulatory) to optimize project, team, and individual performance Drive continuous process improvement, with a specific focus on systems engineering related processes. Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately. Basic Qualifications
Bachelor's degree in a Science, Technology, Engineering, or Math (STEM) field Experience in Systems Engineering in a regulated industry Additional Skills & Preferences
Demonstrated ability to lead multi-functional teams, work effectively across boundaries, and to effectively influence without authority Strong collaboration skills and ability to work productively in an interdisciplinary environment Broad, integrated technical knowledge for system and design engineering, product development, and commercialization in a highly regulated environment Excellent written and verbal communication skills, able to effectively interact at all levels of the organization - business leaders, senior technical/scientific personnel, internal/external customers/suppliers/teammates Previous systems engineering experience, which includes creating systems engineering work products and integrating complex, multi-disciplinary systems utilizing industry standard SE tools and techniques, including model based systems engineering (MBSE) INCOSE certified Systems Engineering Professional (ASEP, CSEP, ESEP) Knowledge of ISO 14971 Experience with Design Control
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 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.
#WeAreLilly