Senior/ System Engineer - Medical Devices

Organization Overview:u00A0

The Product Research and Development (PRD) organization strives to develop and deliver quality medicines to patients. The portfolio consists of development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world.u00A0u00A0

The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a PRD team that works closely with the PRD team in Indianapolis in enabling the delivery of Lillyu2019s portfolio.u00A0

Systems Engineer (LCCI)u00A0

The Delivery, Device and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and container closure systems.u00A0u00A0u00A0

The Device Development Engineer will play a key role in supporting the Design, Development, and Commercialization of medical devices, combination drug/device systems, and drug container closure systems.u00A0
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Key Objectives/Deliverables:u00A0

As a Systems Engineer, you are a key member of the multi-functional team comprised of other technical disciplines (Software, Electrical, Mechanical, Materials, etcu2026) 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 u201Cpiecesu201D 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:u00A0

• Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development processu00A0

• Work with technical lead to drive consistency when developing, managing, and documenting stakeholder needs and requirementsu00A0

• Perform, create, and manage system requirements including but not limited to requirements analysis, development, and allocationu00A0

• Create and manage traceability from requirements (including system risk) to system verification/validationu00A0

• Develop and document system architecture, including preliminary concept development trades-offs and system functional analysisu00A0

• Identify system hazards and perform system risk identification, assessment, and managementu00A0

• Develop and document the system test strategy and lead system integration, verification, and validation activitiesu00A0

• 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 performanceu00A0

• Drive continuous process improvement, with a specific focus on systems engineering related processesu00A0

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Quality Culture:u00A0

Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicating appropriately.u00A0

Minimum Experience QualificationRequirements:u00A0

• Bachelors or Masteru2019s in Engineering (Mechanical, Materials, or Biomedical Engineering) with at least 5 years of relevant Industry experience.u00A0

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Additional Preferences:u00A0

• Demonstrated ability to lead multi-functional teams, work effectively across boundaries, and to effectively influence without authorityu00A0

• Strong collaboration skills and ability to work productively in an interdisciplinary environment.u00A0

• Broad, integrated technical knowledge for system and design engineering, product development, and commercialization in a highly regulated environment.u00A0

• 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/teammatesu00A0

• 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)u00A0

• INCOSE certified Systems Engineering Professional (ASEP, CSEP, ESEP)u00A0