John Simonelli Email & Phone Number

Boston, MA, US

Marlborough, MA, US

• Manage and lead a team of talented Design Assurance Quality Engineers across multiple divisions and sites including screening, skeletal, and breast surgery focused on electromechanical capital equipment medical devices.
• Responsible for assuring our products continue to support our customer’s needs through compliance to design controls, international standards, EU MDR readiness and risk management.
• Establish and lead continuous improvement initiatives to ensure processes remain state of the art and comply with the latest standards including latest regulations around medical device AI.
• Provide mentorship, guidance and support for colleagues through interactive discussions, training and individual development plans empowering growth and impact to the business.
• Ensure risk management files are state of the art to ensure products are safe and effective for customers and users, using tools such as Hazard Analysis and FMEAs.

Marlborough, MA, US

• Served as lead core team representative for design assurance on new product development and sustaining projects, providing guidance aligned with Hologic’s Quality Management System and Design Control process.
• Provided Post Market Surveillance support by assessing complaints, risks and generating Health Hazard Evaluations when deemed appropriate.
• Provided support for the CAPA and NCE process, ensuring improvement to our products and processes.
• Assured user needs and design input requirements were clearly defined, and software and hardware V&V activities were appropriate and compliant.
• Participated in usability activities by providing R&D with input to usability plans, risk analysis, formative and summative studies per IEC 62366.

Marlborough, MA, US

Framingham, Massachusetts, US

• Led Design Assurance related activities for class III electronic medical device peripherals for HeartWare’s Ventricular Assist Device (VAD) by providing key contributions to design control and risk management.
• Provided sample size guidance utilizing a risk-based approach for both Design Verification and Process Qualification including IQs, OQs, PQs and PPQs.
• Oversaw V&V Plans, reviewing and approving test cases for electromechanical components.
• Served as a key contributor for improvements to the Quality Management System, ensuring compliance to standards.
• Reviewed regulatory submissions for both US and EU regulatory bodies.

Framingham, Massachusetts, US

Novi, Michigan, US

• Led quality related activities for products in WIP, incoming, stock, and returns.
• Maintained quality related activities through NCMRs, Quality Correction Reports and Quality Bulletins using the Agile system.
• Actively monitored the production floor and quickly identified non-conforming material.
• Created and maintained process capability studies and control plans for overall product quality.
• Actively involved in troubleshooting with team members using electrical engineering background.
• Held weekly meetings with a cross-functional team to help drive root cause and corrective actions to improve overall stability and quality of products.

Masters, Electrical Engineering

Bachelors, Audio Engineering Technology