Senior Manufacturing Engineering

Sr Manufacturing Engineer - Surgical Innovations

North Haven, CT, 06473 | Job Type: Full-Time

Join a dynamic, innovation-driven team supporting Medtronic's Surgical Innovations manufacturing operations. As a Sr Manufacturing Engineer, you will play a pivotal role in upholding world-class product quality, ensuring regulatory compliance, and championing continuous improvement within a collaborative and inclusive environment.

Develop, implement, and maintain quality standards, protocols, and procedures for advanced manufacturing processes and finished medical device products

• Lead process validation activities throughout the validation lifecycle to ensure consistent product performance
• Drive root cause investigations, manage CAPA and non-conforming material activities, and support inspection/testing strategies for robust manufacturing outcomes
• Collaborate with cross-functional teams in Manufacturing, Operations, and Engineering to enhance process reliability and drive operational excellence
• Conduct statistical analysis to inform data-driven decision-making and continuous process improvement
• Ensure precise documentation and adherence to FDA, ISO, and internal quality management system requirements

Bachelor's Degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related technical discipline

• 7+ years' experience in Engineering or Quality Engineering within medical device or regulated manufacturing environments
• Demonstrated expertise in process validation and quality systems
• Hands-on experience with CAPA, NCMR, root cause analysis, and documentation compliance
• Proficiency in statistical analysis tools such as Minitab
• Experience with FDA, ISO 13485, and medical device regulatory requirements
• Familiarity with risk-based decision making in a regulated manufacturing environment

Opportunities for career advancement within a global leader in medical device innovation

• Inclusive work environment committed to equal opportunity and diversity