Passionate innovator and skilled collaborator with recognized leadership capabilities and a relentless drive to overcome technical and business challenges. Influencer, consensus-builder, and a leader with success in establishing and managing relationships with external partners, executives, and internal multifunctional teams. Over 20 years of demonstrated successful leadership experience in every facet of developing safety critical medical devices. Adept at using strong analytical and technical skills to lead teams in solving complex problems and fulfilling the voice of the customer. Proven track record of efficiently deploying process improvements with extensive knowledge of 21 CFR 820 and ISO 13485. Specialties:- Safety Critical Real time embedded systems.- Requirement management- Safety Risk Management- FDA and EU standards- Product development best practices- Combination products- MDSAP- EU MDR- SaMD- AI/ML