Senior Systems Engineer-Delivery and Device
State / Province
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.
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.
Are you seeking a career that makes a difference in the world? Do you enjoy translating complex, abstract problems into tangible, bite-sized technical descriptions that can be implemented by multi-functional teams? We are seeking a highly motivated Systems Engineer to join our DDCS team. DDCS Systems Engineers are key technical members of multi-functional teams comprised of various technical and functional disciplines such as Software, Electrical, Mechanical, Human Factors, and Materials Engineering, as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety. They develop capabilities across multiple, complex systems and system of systems to provide seamlessly integrated device solutions. Key responsibilities include the following:
- Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process
- Elicit needs and requirements from stakeholders; create, allocate, and manage system requirements; collaborate with technical functions to create subsystem and interface requirements
- Create and manage requirements traceability to system risk, verification, and validation
- Design/develop system architectures that incorporate flexibility, adaptability, modularity, and scalability to maximize reuse and interoperability / integration
- 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
- Drive continuous process improvement, with a specific focus on systems engineering related processes
- Provide systems engineering related coaching, mentoring, and training to colleagues and team members
- Bachelorâs degree in an Engineering or Math field
- 2+ years systems engineering experience within a regulated industry (Medical device, automotive, aerospace & defense, etcâ¦)
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Advanced Engineering or Math degree
- Possesses a passion for systems engineering and evangelizes the benefits of systems thinking across the organization
- 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 60601, ISO 11608, ISO 14971, IEC 62366, etcâ¦)
- Demonstrated experience and in depth knowledge of systems engineering including but not limited to requirements elicitation / development / traceability / management / allocation, interface definition and management, system architecture development, enterprise architectures, technical planning and risk assessments, system level risk assessments (patient safety), trade-offs, system modeling and simulation, system integration, verification and validation planning and execution, model-based systems engineering (MBSE)
- Demonstrated ability to lead multi-functional teams, reach across boundaries, and effectively influence without authority
- Excellent written and verbal communication; able to establish and maintain strong working relationships with all levels of the internal organization across multiple functions and disciplines as well as with external suppliers, stakeholders, partners; capable of translating complex technical information into management level communications
- Familiar with one or more requirements, architecture, and/or MBSE software tools and experience in both structured (i.e. waterfall) and iterative (i.e. Agile) development methodologies
- INCOSE certified Systems Engineering Professional (ASEP, CSEP, ESEP)
- Location is at Lilly Technology Center â North, Indianapolis, IN
- Ability to travel up to 10% of the time both domestic and international
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an outstanding work environment:
- Business Week magazine 50 Best Places to Launch a Career
- Black Enterprise 2018 list of 50 Best Companies for Diversity
- FORTUNE 50 Best Companies for Minorities
- Human Right Campaign Corporate Equality Index - 100% score
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.