Regulated Medical Device Process Engineer

Kaztronix LLC; Raynham (MA); On-site; USD 70,000 - 85,000; Full time

Job summary

A leading engineering firm in Raynham, MA is looking for a Manufacturing/Process Engineer. In this role, you will write and execute validation protocols, develop manufacturing processes, and ensure compliance with FDA regulations. Strong technical writing and communication skills are essential, along with 2-4 years of experience in a regulated environment. This position offers opportunities to collaborate with multi-functional teams and engage in continuous process improvement initiatives.

Qualifications

• 2-4 years of experience in manufacturing and/or process engineering.
• Experience in a Medical Device and/or regulated manufacturing environment.
• Knowledge of statistical data analysis.

Responsibilities

• Write and execute validation protocols and reports.
• Develop and implement manufacturing processes.
• Ensure compliance with FDA regulations.

Skills

Technical writing skills

Communication skills

Process validation

Digital literacy

Interpersonal skills

Education

Bachelor of Science Degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related

Tools

Microsoft Office

Minitab

Job description

A leading engineering firm in Raynham, MA is looking for a Manufacturing/Process Engineer. In this role, you will write and execute validation protocols, develop manufacturing processes, and ensure compliance with FDA regulations. Strong technical writing and communication skills are essential, along with 2-4 years of experience in a regulated environment. This position offers opportunities to collaborate with multi-functional teams and engage in continuous process improvement initiatives.