Lafayette, CO30+ days ago
Must Have CAPA Medical Device Risk Management RPM Quality Nice to Have 10 Years design experience in the medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience Program Management/Project Management Top 3 Technical Skills Required Manufacturing experience Medical device risk management Compliance effective oversight Education and Experience Bachelor’s Degree in Engineering, Science, or a technical field with a minimum of 6 years of work experience in Engineering and/or Quality. While this role does not support day-to-day manufacturing operations, a strong understanding of manufacturing processes (e.g., injection molding, ultrasonic welding, etc.) is essential for evaluating the impact of design changes on product quality and process capability.