Process Engineers - 4 years +

Medtronic seeks manufacturing engineers with 4+ years of experience to lead process development, optimization, and continuous improvement initiatives for medical device production in Puerto Rico. The role partners across operations, quality, and R&D to enhance manufacturing performance, ensure regulatory compliance, and support product scalability.

Responsibilities

• Lead development, optimization, and sustainment of manufacturing processes for quality and efficiency improvements
• Drive continuous improvement using statistical methodologies to reduce waste and enhance process capability
• Identify and implement equipment, tooling, and automation enhancements supporting operational objectives
• Partner with R&D to ensure designs are manufacturable and scalable; support technology transfer and new product introductions
• Lead risk assessments using FMEA and other tools; support engineering changes and regulatory compliance initiatives

Requirements

• Bachelor's degree in Engineering with 4+ years manufacturing experience, or Master's with 2+ years, or PhD
• Proficiency in Lean Manufacturing and Six Sigma methodologies in regulated environments
• Advanced statistical analysis skills including DOE, SPC, MSA, and process capability studies
• Experience leading equipment qualifications and validation activities (IQ/OQ/PQ)
• Knowledge of FDA QSR, ISO 13485, GMP, and quality system requirements
• Experience supporting nonconformance investigations and CAPA initiatives