Sean K Email & Phone Number

-Drove multiple concurrent projects focusing on delivering high-quality risk management files. Excelled in proactively identifying and mitigating potential issues, ensuring alignment with Class III medical industry standards, and meeting customer expectations.Process Improvements and GTIN Optimization: -Championed innovative solutions to enhance project development speed and efficiency, including streamlining the GTIN process for product releases. This strategic approach significantly reduced the time to market software products while maintaining a meticulous balance between enhancements and strict compliance with quality standards, resulting in optimized project outcomes and ensuring regulatory adherence.Risk Management and Audits: -Led and successfully defended risk management during internal audits, achieving zero major findings by the reviewer.Regulatory Compliance and Efficiency: -Actively managed and expedited responses to regulatory submission deficiencies, leveraging extensive product development expertise. This proactive approach significantly accelerated the approval process.Process Development for Software Maintenance: -Developed and implemented a new process using field qualitative complaint data to prioritize software maintenance releases. This process enhanced customer satisfaction and product quality, becoming a benchmark for issue prioritization within the PCS quality team.

Sylmar, Ca

Program Management: -Demonstrated exceptional skills in launching global Class III software releases, consistently upholding exemplary quality standards.Leadership & Coaching: -Led a robust, high-performance software verification team overseeing multi-billion-dollar medical device projects, including software and mobile applications.Technical & Problem Solving: -Played a pivotal role in field investigations, enhancing product reliability and customer satisfaction.Consistent Professional Growth: -Over 20 years at Abbott with rapid career progression from Test Engineer to leadership roles. Evolved within Abbott with promotions every 2 to 6 years, reflecting a strong professional success and development record.

Sylmar, Ca

Project Leadership and Program Management Excellence: Led multiple Class III software releases for $3 billion Implantable Medical Device products, achieving a record number of launches by reducing the Software Development Life Cycle (SDLC) by 25%, resulting in $5,000 savings per release. Demonstrated outstanding program management by innovating in software verification for a new-generation platform, managing over 30,000 requirements. This approach led to unprecedented on-time delivery records for multi-million-dollar projects, significantly enhancing quality standards and operational efficiency. Reliability Testing and Innovative Test Automation Leadership: Directed reliability testing for software upgrades, significantly enhancing product reliability by reducing software errors to a mere 0.01%. Additionally, engineered and executed innovative testing methods and managed a comprehensive test automation suite, achieving a 50% reduction in test development time and a 30% increase in efficiency per test cycle. These strategic initiatives led to substantial savings of over $278,000 and marked improvements in operational efficiency and product quality.

Sylmar, Ca

Acted as a key member of field issue investigation boards, driving detailed root cause analysis, risk assessment, and effective issue resolution, which were crucial for maintaining product integrity and customer trust.Played a pivotal role as a software team member in defending against rigorous FDA and TÜV audits, contributing to the successful resolution of compliance challenges and the removal of a critical warning letter.

Sylmar, Ca

Team Building and Leadership: -Successfully recruited and established a high-performing software verification team of over 30 professionals, including direct supervision and career development of 6 engineers and 2 junior managers. Implemented a robust mentorship and cross-training program, transforming the team into Subject Matter Experts (SMEs), thereby enhancing product understanding and quality.Leadership During Crisis: -Led the onsite team effectively through the unprecedented challenges of the COVID-19 pandemic. Adapted strategies and ensured the team's well-being and productivity, maintaining essential operations during critical times.

Ms, Biomedical Engineering

Bs, Economics And Physics

Bachelor Of Science - Bs, Systems Science And Engineering