Manufacturing Engineer

Job Title: Manufacturing Engineer

Location: Raynham, MA (Onsite)

Duration: Contract

Project Overview:

We are seeking a hands-on Manufacturing Engineer to support validation activities, process development, equipment commissioning, and regulatory compliance in a medical device manufacturing environment. The ideal candidate will have experience executing IQ/OQ/PQ protocols and working under FDA regulations.

Job Description:

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.