Lilly has created a Digital Devices team which is responsible for the development and scale-up of new devices for late stage clinical trials and commercial distribution. We view this “digital disruption” in healthcare as a tremendous opportunity to better serve our patients. This team consists of internal and external capabilities in electronics, wireless connectivity, and software development (device, mobile app, and cloud). This team is responsible for managing the development of innovative user experiences, and for understanding and influencing emerging digital standards and regulations. Lilly IDM QA plays a key quality role in partnering with the Digital Devices team to oversee the development and delivery of iOS and Android-based mobile medical apps. This position reports to the Director of Lilly IDM QA, and will have accountability for Quality oversight of product development, release, and maintenance of MMAs. This position will plan, direct, and coordinate all quality compliance activities, focusing on product development lifecycle using agile development methods, ensuring compliance with applicable medical device regulations. The candidate will also support other tasks such as purchasing controls or due diligence activities as needed. The role is accountable for understanding and guiding Lilly’s emerging software development needs per current Lilly and regulatory requirements. This role will participate in planning to support our MMA development and maintenance needs. This participation requires the ability to influence project teams on the development and maintenance of compliant MMA products by leveraging and integrating Lilly and vendor processes and tools. Knowledge Requirements: All aspects of software product development under design controls.Practical understanding of ISO 13485:2016 and FDA’s Quality System Regulation. Practical understanding of software development life cycle principles, and design controls per ANSI 62304 and ISO 12207.Practical understanding of risk management per ISO14971, and human factors per AAMI HE75 and IEC62366,Practical understanding of developing and communication of software metrics (trends, anomalies, requirements tested, test suite status, level of code reviews, etc.). Practical understanding of design verification and design validation for software and hardware. Experienced with performing regulatory compliance reviews and auditing. Experienced working with software development teams under multiple product development projects. Responsibilities: Define compliance requirements for project teams and participate in identifying specific software deliverables. Ensure Quality Management System compliance by providing updates to procedures as appropriate. Participate in Root Cause Investigations. Ensure software development, risk management, human factors activities, tasks and deliverables are complete by conducting Design Control document reviews and Phase audits. Up to 10% international travel.
Bachelor’s degree in engineering, computer science, software engineering or scientific discipline with 2+ years of experience in a regulated software and/or firmware commercialization environment OR High School Diploma/GED with 2+ years relevant experience working directly with mobile medical apps in a quality or regulatory function
Experience managing multiple tasks concurrently
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
This position reports to the Director of Lilly IDM Quality and will have accountability for quality governance and oversight for MMAs/SaMDs. 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.