Sally Carter

About Sally Carter

Experienced Medical Device Engineering Leader, managing projects from concept through post-launch including generating IP resulting in patents. Knowledgeable on medical device regulations and clinical environments, leveraging experience to coach and mentor teams across the organization.Specialties: Design control, testing, project management, medical device development and engineering, concept generation, surgical technique, training, and testingExperience Summary:MEDICAL DEVICE LEADER with over 15 years of experience in research and development resulting in multiple patents. Managed direct and indirect teams of various sizes and at multiple site locations. Led projects across all stages from concept to post-launch with a strong quality systems focus. Skilled in understanding the clinical requirements and finding engineering solutions within regulatory boundaries. Versatile engineer, learned new technology quickly, energized by research into new surgical technique areas, and proposed creative solutions to problems. Developed implants and instruments across multiple platforms including endoscopy, vascular, orthopedics, and sports surgery. Taught medical device development best practices and mentored series of co-ops and inexperienced engineers.

Experience

1. Director of Application Engineering and Quality

   Cognition Corporation

   Aug 2022 — Present · Lexington, MA, US

   Building team focused on customer success. Creating content related to medical devices, improving quality management system to align with ISO 9001, guiding team in continuous improvement of processes, training, documentation, quality, and supporting our customer\'s success.As Quality Officer, supporting audits both internal and external of our QMS.

Education

• University of Massachusetts Amherst

  BS, Mechanical Engineering

  1994 — 1998

• Worcester Polytechnic Institute

  Masters of Engineering, Biomedical Engineering

Skills

• Surgical Technique Knowledge
• Injection Molding
• Quality System
• V&V
• Endoscopy and Anastomosis
• Catheters and Stents
• Risk Management
• Fda
• Arthroscopy & Sports Medicine
• Engineering
• Root Cause Analysis
• Design of Experiments
• Manufacturing
• Biomechanics
• Medical Devices
• Capa
• Tissue Engineering
• R&D
• Biomedical Engineering
• Tissue Mechanics
• Laparoscopic Surgery
• Research and Development (R&D)
• Solidworks
• Project Management
• Catheters
• Iso 13485
• Spine
• Biomaterials
• Commercialization
• Mechanical Testing
• Spc
• Orthopedic
• Concept Generation
• Product Launch
• Dhf
• Validation
• Minitab
• Training
• Medical Device R&D
• Testing