Senior Manufacturing Engineer

Intellectt Inc; North Haven (CT); On-site; USD 110,000 - 140,000; Full time

Job summary

Medtronic in North Haven seeks an experienced Sr. Manufacturing Engineer to provide technical leadership and daily manufacturing support for multiple product families.

The role emphasizes improving product quality while reducing costs and optimizing processes in a regulated medical device environment. The candidate will collaborate with Production, Quality, Operations, Supplier Quality, and Engineering teams, perform root cause analyses, and drive CAPA/PFMEA actions with strong problem-solving

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, or Industrial Engineering.
• 7+ years of manufacturing engineering experience in medical devices or regulated industries.
• Strong knowledge of manufacturing processes, process validation, quality systems, and regulatory requirements.
• Hands-on experience with root cause investigations and manufacturing process improvements.

Responsibilities

• Provide technical leadership and daily manufacturing support for multiple product families within manufacturing operations.
• Maintain and improve product quality while reducing manufacturing costs and optimizing processes.
• Ensure compliance with safety, quality, and regulatory requirements.
• Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate manufacturing issues and identify root causes.
• Perform root cause analysis and implement corrective and preventive actions.
• Support process validation activities, manufacturing process development, and equipment improvements.
• Drive continuous improvement and operational excellence initiatives.
• Lead and participate in cross-functional projects related to manufacturing, quality, and process improvement.
• Apply CAPA, PFMEA, and medical device quality system principles as required.

Skills

Root cause investigations

Project management

Leadership

Problem solving

Lean Manufacturing

Six Sigma

Regulatory compliance

Cross-functional collaboration

Education

Mechanical Engineering

Manufacturing Engineering

Industrial Engineering

Job description

We are seeking an experienced Sr. Manufacturing Engineer to provide technical leadership and daily manufacturing support for multiple product families within Medtronic's North Haven manufacturing operations. The ideal candidate will have strong experience in manufacturing engineering, process improvement, quality systems, and regulated manufacturing environments, preferably within the medical device industry.

Key Responsibilities

• Provide technical leadership and daily manufacturing support for multiple product families within manufacturing operations.
• Maintain and improve product quality while reducing manufacturing costs and optimizing manufacturing processes.
• Ensure compliance with safety, quality, and regulatory requirements.
• Partner with Production, Quality, Operations, Supplier Quality, and Engineering teams to investigate manufacturing issues and identify root causes.
• Perform root cause analysis and implement effective corrective and preventive actions.
• Support component qualification and manufacturing process improvements.
• Drive continuous improvement and operational excellence initiatives.
• Support process validation activities, manufacturing process development, and equipment improvements.
• Lead and participate in cross-functional projects related to manufacturing, quality, and process improvement.
• Apply strong problem-solving, technical communication, project management, and leadership skills to resolve complex manufacturing challenges.
• Utilize Lean Manufacturing and Six Sigma methodologies to improve processes, quality, and operational efficiency.
• Apply CAPA, PFMEA, and medical device quality system principles as required.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• 7+ years of experience in manufacturing engineering, preferably within the medical device or other regulated industries.
• Strong knowledge of manufacturing processes, process validation, quality systems, and regulatory requirements.
• Hands-on experience with root cause investigations and manufacturing process improvements.
• Experience executing cross-functional projects and working with multidisciplinary teams.
• Strong technical problem-solving, project management, communication, and leadership skills.

Preferred Qualifications

• Experience with Lean Manufacturing and Six Sigma methodologies.
• Experience with CAPA and PFMEA.
• Experience working within medical device quality systems.
• Experience with manufacturing process development, validation, and equipment improvement initiatives.