Sr Manufacturing Engineer

Indotronix International Corporation • North Haven, CT

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About The Position

Join Medtronic’s Surgical Innovations team supporting manufacturing operations. The Sr Manufacturing Engineer helps uphold product quality, ensure regulatory compliance, and champion continuous improvement in a collaborative and inclusive environment. The role focuses on quality standards and procedures, process validation, investigations and corrective actions, statistical analysis, and compliance with applicable regulations and quality management systems.

Requirements

• Bachelor’s degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related technical discipline.
• At least 7 years of 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.
• Strong analytical, problem-solving, and communication skills.

Nice To Haves

• Experience with FDA, ISO 13485, and medical device regulatory requirements.
• Familiarity with risk-based decision-making in a regulated manufacturing environment.

Responsibilities

• 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 and manage CAPA and non-conforming material activities.
• Support inspection and testing strategies for robust manufacturing outcomes.
• Collaborate with Manufacturing, Operations, and Engineering teams to improve process reliability and operational excellence.
• Conduct statistical analysis to inform data-driven decision-making and continuous process improvement.
• Maintain precise documentation and ensure adherence to FDA, ISO, and internal quality management system requirements.

Benefits

• Competitive compensation and benefits package.
• Opportunities for career advancement within a global leader in medical device innovation.
• Inclusive work environment committed to equal opportunity and diversity.
• Professional development and cross-functional collaboration.
• Support for reasonable accommodations throughout recruitment and employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior