Sr. Manufacturing Engineer

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

We are seeking a Sr. Manufacturing Engineer to provide technical leadership and daily manufacturing support for multiple product families within a regulated manufacturing environment. This role will focus on maintaining and improving product quality, reducing manufacturing costs, optimizing manufacturing processes, and ensuring compliance with safety and regulatory requirements. The engineer will collaborate closely with Production, Quality, Operations, Supplier Quality, and Engineering teams to resolve manufacturing issues and drive process improvements.

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.

Required 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.

Preferred Qualifications:

• Experience with Lean Manufacturing.
• Six Sigma experience or certification.
• Experience with PFMEA.
• Experience with equipment improvement and manufacturing cost reduction.
• Experience collaborating with Supplier Quality teams.
• Experience with operational excellence initiatives.
• Experience in FDA-regulated manufacturing environments.
• Knowledge of ISO 13485, GMP, or other applicable regulated-industry standards.
• Experience supporting multiple product families.
• Experience with validation protocols and reports.
• Medtronic or medical device manufacturing experience.

Work Requirements:

• This position is onsite in North Haven, CT.
• Candidates must be able to work in a regulated manufacturing environment and support daily manufacturing operations.
• OPT and CPT candidates are not eligible for this position.

Equal Opportunity Employer:

We are an equal opportunity employer committed to providing a workplace free from unlawful discrimination and harassment. Employment decisions are based on qualifications, experience, business needs, and applicable law.