Senior Manufacturing Engineer — Regulated Medical Devices

Intellectt Inc; North Haven (CT); On-site; USD 110,000 - 150,000; Full time

Job summary

Intellectt Inc in North Haven, CT is seeking a Sr. Manufacturing Engineer to provide technical leadership and daily manufacturing support for multiple product families in a regulated environment.

You will drive process improvements and collaborate with Production, Quality, Operations, Supplier Quality, and Engineering to resolve issues and reduce costs. The role requires 7+ years in manufacturing engineering, experience in medical device or regulated settings, and strong problem-solving, project

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• 7+ years of manufacturing engineering experience.
• Experience in medical device manufacturing or another regulated manufacturing industry.
• Strong knowledge of manufacturing processes and process development.
• Experience with process validation activities.
• Experience performing root cause investigations and implementing corrective actions.
• Experience with quality systems and regulatory requirements.
• Demonstrated experience with manufacturing process improvement and optimization.
• Experience supporting cross-functional manufacturing projects.
• Strong problem-solving, technical communication, project management, and leadership skills.

Responsibilities

• Provide technical leadership and daily manufacturing engineering support for multiple product families.
• Develop, improve, and optimize manufacturing processes to enhance quality, efficiency, and cost effectiveness.
• Investigate manufacturing issues and perform root cause analysis.
• Develop and implement corrective actions, including CAPA-related activities.
• Support component qualification and manufacturing process development activities.
• Support process validation activities, including validation protocols and reports.
• Identify and implement equipment and process improvements.
• Lead and support continuous improvement and operational excellence initiatives.
• Collaborate with Production, Quality, Operations, Supplier Quality, and Engineering teams on manufacturing challenges and improvement projects.
• Support compliance with applicable safety, quality, and regulatory requirements.
• Apply manufacturing engineering principles to improve product quality and reduce manufacturing costs.
• Support cross-functional projects and communicate technical information effectively to stakeholders.
• Contribute to Lean Manufacturing and Six Sigma improvement initiatives where applicable.

Skills

Problem solving

Technical communication

Project management

Leadership

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering or related field

Job description

Intellectt Inc in North Haven, CT is seeking a Sr. Manufacturing Engineer to provide technical leadership and daily manufacturing support for multiple product families in a regulated environment.

You will drive process improvements and collaborate with Production, Quality, Operations, Supplier Quality, and Engineering to resolve issues and reduce costs. The role requires 7+ years in manufacturing engineering, experience in medical device or regulated settings, and strong problem-solving, project