• Design Controls subject matter expert managing process and compliance to process supporting Abbott Diabetes Care R&D team. • Partner in optimizing, streamlining, and increasing compliance with design control requirements for Abbott Diabetes Care products: hardware, embedded software, and SaMD. • Lead process development and process improvement projects with world-wide cross-functional teams. • Conduct training on general design controls. • Develop and deliver training specific to process changes. • Demonstrate leadership in change management practices. • Ensure conformity of processes and records to global regulatory standards and internal policies and procedures. • Audit design records as required to ensure conformance; work with R&D and QA teams to evaluate and remediate non-conformances. • Perform gap analyses to international regulatory standards and guidance and propose policy and procedure updates to conform. • Maintain expertise in global design controls and design and development standards and guidance including ISO13485, ISO14971, 21CFRPart820, MDSAP, IEC60601, IEC62304, IEC62366, Agile software development, etc. • Train and mentor R&D and QA resources in subject matter expertise to ensure alignment and acceptance of organization with policies and procedures. • Participate in audits (FDA, ISO, Partner, internal) as a R&D representative and design controls expert. • Build technical knowledge of the business product portfolio and maintain awareness of program initiatives and product ecosystem developments. • Partner with R&D resources to ensure alignment and compliance when choosing and implementing software tools for design and development activities.