Manufacturing 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

Responsibilities

• Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.)
• Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation.
• Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system.
• Working with OEM equipment manufacturers and distributors to develop user requirements.
• Work on new asset commissioning
• Working with multi‑functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals.
• Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

Education

• Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.

Experience and Skills

Required

• 2-4 years of experience in manufacturing and/or process engineering.
• Strong technical writing skills, with appropriate awareness of intended audience.
• Ability to effectively communicate across multiple audiences, including operators, peers and management, in both written and oral manners.
• Process validation experience.
• Experience in a Medical Device and/or regulated manufacturing work environment.
• Persuasive communication and interpersonal skills.
• Digital literacy, including use of Microsoft Office tools.

Preferred

• Experience working in a regulated industry, such as Medical Device.
• Experience with machining processes, metal finishing processes, laser processing or production automation.
• Hands‑on experience with machining processes, casting, metal finishing processes, laser processing or production automation.
• Knowledge of statistical data analysis and associated tools (e.g. Minitab).
• Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Willingness to support global projects, which may include travel.