I am an experienced senior-level professional with broad product development and commercial introduction experience.
I have 16 years of experience in the highly regulated Healthcare / Medical Device industry and and 12 years experience working with the high-availability and security sensitive government and public safety communications market.
I am an active leader and promoter of Agile framework and a mentor to others who are learning to work within the framework. The emphasis today is on widening system access and interoperability needs that place much greater demands on teams to be agile, while delivering safe and effective solutions within the regulatory framework. As a leader with experience across Development, Quality and Regulatory areas, I emphasize adherence to regulation and coach teams on the proper way to maintain their agility within those bounds.
GE Healthcare Digital, Senior Manager, Software Development
June 2001 - Present, , IL, US
Lead engineering and commercial release teams in the Medical Device Industry driving new product development and commercial introduction.
Ensure compliance to industry standards and regulations and stay prepared for regulatory audits, Lead investigations, Execute CAPA's and Define and Implement remediation activities.