Lilly Cnslt Engr-IDM-Software Prod Steward in Indianapolis, Indiana
Indy Device Manufacturing is responsible for globally commercializing and overseeing product launch and life-cycle management for drug delivery devices and their connections to digital health. As the connected care product steward you would be responsible for the global software lifecycle development, specifications, materials and technical agendas for one or multiple Lilly connected device platforms. This role will utilize your knowledge of mobile medical apps/embedded software/hardware, device regulatory standards & requirements, and engineering principles. You will collaborate on a daily basis with IT, Regulatory, R&D, and Quality groups to ensure superior drug delivery products. Additionally, you will be an external face of device manufacturing with third party vendors and collaborators. Position responsibility might include:
Ensure MMAs and embedded product software for connected devices remain in a state of compliance by maintaining design controls, risk management, complaint analyses consistent with local procedures, international standards, and regulatory requirements.
Own changes for improving marketed products, including multiple designs/versions associated with multi-generational products.
Analyze field feedback through product complaints, product reviews, usage analytics, and other methods to identify improvement opportunities for marketed products.
Partner with development to provide input as related to software platform strategy, software architecture, and detailed design. This includes debugging existing designs and in developing reliability improvements for software
Support usability testing and human factors engineering, including working with customers to create and refine user interfaces as required.
Recommend mobile platform and architecture based on project requirements and industry best practices – includes choice of technology and development methodology.
Participate in selection of mobile implementation vendors, project scope identification and playing the critical role of a liaison between external vendors and internal software product development team.
Mobile Application Development
Experience in working with external vendor or collaborators and managing their resources/project timelines/risks
Experience writing embedded device drivers, developing and debugging software on embedded processors utilizing JTAG or similar debugging tools
Experience developing in Linux environment and familiarity with Qt
Deep technical expertise and ability to be integrally involved in, the entire SDLC in an Agile SCRUM environment
A thorough understanding of OOP, design patterns, iOS, android, and enterprise in mobile application integration
Demonstrated deployments of enterprise or consumer-facing mobile software systems using industry standard environments including iOS, android Understanding of mobile security protocols, analytics and social channel integration. C and/or C++ Language Skills.
Medical device or other safety critical device development.
Knowledge of ISO 13485, ISO 14971, IEC 660601 and IEC 62304 are highly desirable
Knowledge of drug product and medical device regulatory requirements (especially cGMP, 21 CFR 820, ISO 13485, ISO11608)
Expertise in iOS, android, HTML5, CSS3, and other mobile frameworks/accelerators
- 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.
Software Development Lifecycle Manager-Connected Devices
Engineering Bachelor's Degree (Computer Science, Systems or Electrical Engineer) with minimum 3 years of experience in delivering solutions on mobile and/or embedded software platforms.
Minimum 3 years of experience in building mobile solutions that integrate with enterprise applications
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
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.
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