Systems Engineer - Medical Device at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

171600.0

Posted On

08 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Systems Engineering, Medical Devices, Risk Management, Requirements Analysis, System Architecture, Verification, Validation, Collaboration, Communication, Process Improvement, Quality Mindset, Technical Leadership, Interdisciplinary Work, ISO 14971, Design Control, Model Based Systems Engineering

Industry

Pharmaceutical Manufacturing

Description

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. Position: Systems Engineer, DDCS Location: Lilly Technology Center-North (LTC-N) Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. 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. Position Summary: As a Systems Engineer, you are a key member of multi-functional teams 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. Responsibilities: Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process Work with technical leads 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 Requirements: Bachelor’s degree in a Science, Technology, Engineering, or Math (STEM) field Experience in Systems Engineering in a regulated industry, or experience working on medical devices 2+ years of work experience, relevant internships will be considered Additional 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 Additional Information: Travel: 0 to 10% Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N) 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 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 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. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly

Responsibilities

As a Systems Engineer, you will be responsible for system level design inputs and outputs, managing requirements, and leading system integration and validation activities. You will work with multi-functional teams to ensure all technical disciplines are integrated throughout the development process.