Test Lead–Digital Health
Indianapolis, IN
About the Position
Digital Health Organization Overview
Technology continues to transform every aspect of society, including healthcare. Lilly sees digital as an extension of our medicines, not just a marketing tactic. We, as consumers, have come to expect digital experiences to augment and support our experiences with medicines – especially to help reduce the burden of coping and managing through chronic disease for us, our loved ones and health care providers. Hence, Lilly’s Digital Health team is committed to exploring how the next generation therapeutic ecosystems, connected solutions, and data analytics can transform the customer (patients, health care providers and payers) experience, demonstrate value, and most importantly – improve patient outcomes.
Primary Purpose
The Test Lead is part of the Software Development team with the Digital Health organization. This position will create and drive the testing strategy and processes to ensure optimal performance of Lilly’s Digital Health platforms. Because Lilly’s products directly impact the health of our customers, the testing role is a critical part of delivering high quality and reliable digital products. The Test Lead will proactively implement solutions to address testing challenges and maintain quality in sync with the evolution of the Digital Health systems, drive buy-in and adoption of principles and proposals, and oversee the creation of methods and output. This position will report to the Software Development Advisor.
Requirements
Testing Protocol Development
- Define and implement software development test strategy and protocols to ensure digital products comply with local procedures, international standards, and regulatory requirements, including ISO 13485, 21 CFR 820.30, and MDD 93/42/EEC
- Create and maintain a multi-year roadmap for improvement and creation of testing protocols
- Oversee the planning and development of tests to verify compliance to specifications
- Own applicable risk management deliverables and processes for monitoring, management and automation (MMAs) software development projects, including risk management plans, software hazard analysis, and safety assurance cases that comply with international standards, including ISO 14971
- Apply understanding of regulations, guidance, and standards to manage software testing and change management processes throughout the product lifecycle, including multiple designs/versions associated with multiple generational products
- Stay abreast of industry trends and regulation changes in the Health Information Technology space
Testing Protocol Implementation
- Direct the execution of the testing protocols by providing leadership, training, and mentoring on testing protocols to appropriate Digital Health teams
- Own the requirement gathering, oversee the interpretation of standards, manage the documentation system requirements, and evaluate design options to ensure compliance of test protocols and on-time completion of testing related projects
- Lead organizational change management for the adoption of new testing protocols
Partnership Management
- Oversee Lilly vendors developing MMAs or providing testing services, ensuring proper processes and procedures are in-place and compliant with IEC 62304
- Uncover and develop partnership opportunities across Digital Health and beyond to further streamline testing processes
- Ensure understanding and alignment on goals and objectives across all internal and external partners
Basic Qualifications
- Bachelor’s degree in Computer Science, Management Information Systems, or relevant information technology program
- 5+ years of experience leading software development testing function
- 3+ years of experience working with vendors and collaborations
- 1+ years of experience working with Software as Medical Device within US
- 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
Interested in applying to this career opportunity?
Please email Taylor Frank, [email protected], and include Test Lead–Digital Health in the subject line.
About Eli Lilly and Company
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.
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.
