Jarrell McWilliams

Background

About Jarrell McWilliams

As a seasoned Medical Device Professional with 25 years in the industry, I currently lead as the Head of Systems Engineering at Bayer Pharmaceuticals. Additionally, I offer specialized consulting services to medical device companies. My expertise lies in leveraging strategic, compliance-focused, and results-driven approaches to achieve critical goals for every project and client. Colleagues know me for my consultative nature, solutions-oriented mindset, and ability to navigate complex issues with flexibility, adaptability, and a calm demeanor. Key achievements in my career include-Achieving IEC 60601-1 and IEC 60601-1-2 certifications: Successfully enhanced product safety and compliance for multiple clients-Implementing ISO 14971 processes: Effectively mitigated risks and ensured product safety across various projects-Creating technical documentation for 510(k) submissions: Developed detailed reports and compliance evidence, securing multiple 510(k) clearances. I am passionate about upholding the highest standards in medical device development. I thrive on driving compliance, improving processes, and leading cross-functional teams to success. Let's connect to discuss medical device risk management, standards and regulatory compliance, and new product development. I look forward to connecting with you here on LinkedIn