Lilly Systems Engineer in Indianapolis, Indiana
Type of Employment:
Full-Time Employment - FTE
In 1992, Eli Lilly and Company established the Delivery, Device, and Connected Solutions (DDCS) business for the purpose of creating, 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 delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. This business enables almost $4.0 billion in pharmaceutical sales and is projected to double in the next 6 years.
We are seeking a highly motivated and innovative Systems Engineer to join our DDCS team. You will be a key technical leader of a multi-functional team comprised of various technical and functional disciplines Software, Electrical, Mechanical, Human Factors, and Materials Engineering, as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety. You will develop and integrate capabilities across multiple, complex systems and system of systems to provide seamlessly integrated connected device and digital health solutions. Key responsibilities include the following:
Engage and partner with internal and external stakeholders to elicit needs, understand context and environment, identify problems to be solved, facilitate/mediate the deconfliction of needs, and manage expectations throughout the lifecycle.
Lead the following systems engineering activities: systems engineering planning, business analysis, concept definition, system architecture and requirements analysis & development, IV&V (integration, verification, and validation) planning and execution, system risk assessments
Perform trade studies and analysis of system architectures
Define optimal system configurations and key capabilities as well as key safety, performance, and interface requirements
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 systems engineering process improvements and provide systems engineering related coaching, mentoring, and training to colleagues and team members
May be assigned a Technical Lead on complex programs serving as the single point of technical accountability for successful delivery of the technical solution.
Bachelor’s degree in an Engineering, Math, Computer Science, or Physics field
Advanced degree in Systems Engineering or a Science, Technology, Engineering, or Math (STEM) field
6+ years systems engineering experience within a regulated industry such as medical device, healthcare, automotive, aerospace & defense
Possesses a passion for systems engineering and evangelizes the benefits of systems thinking across the organization
Familiar with ISO 15288 and experience with FDA class II or III medical device regulatory requirements with knowledge of drug product and medical device standards (i.e. cGMP, 21 CFR 820, ISO 13485, IEC 62304, IEC 60601, ISO 11608, ISO 14971, IEC 62366)
Experience in feature-based Product Line Engineering (PLE) methodologies, approaches, and tools as well as familiarity with ISO/IEC 26550
Exemplary soft skills and demonstrated ability to become an expert in the stakeholder’s environment, understand the patient need(s) and desired user experience, and translate that voice of customer into requirements and trade-offs that can be evaluated
Demonstrated ability to lead multi-functional teams, work effectively across boundaries, and effectively influence without authority to drive organizational culture change; strong collaboration skills and ability to work productively in an interdisciplinary environment.
Excellent written and verbal communication skills, able to convey complex technical information to the lowest common denominator; able to effectively interact at all levels of the organization - business leaders, senior technical/scientific personnel, internal/external customers/suppliers/teammates
Hands on experience with requirements management and architecture tools. Familiarity with SysML and model-based systems engineering (MBSE)
Experience in both structured (i.e. waterfall) and iterative (i.e. Agile) development methodologies
INCOSE certified Systems Engineering Professional (ASEP, CSEP, ESEP)
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
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application processes please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.
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 39,000 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.
Region: North America
Req Id: 55359BR