Medical Device Manufacturing Engineer – Process Validation

VOLTO Consulting; Raynham (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

VOLTO Consulting is seeking a Manufacturing Engineer in Raynham, MA to support process development, validation, and production readiness in a regulated medical device environment.

The role emphasizes hands‑on IQ/OQ/PQ, process engineering, and cross‑functional collaboration with Operations, Quality, Planning, and Engineering teams to drive continuous improvement and compliance with FDA requirements.

Qualifications

• 2-4 years of manufacturing or process engineering experience.
• Bachelor's degree in Engineering or related discipline preferred.
• Strong communication and interpersonal skills.
• Ability to work effectively with cross‑functional teams.

Responsibilities

• Author and execute validation protocols and reports including IQ, OQ, and PQ.
• Develop and implement manufacturing processes and production procedures.
• Support process studies, investigations, root cause analysis, and corrective actions.
• Update manufacturing specifications, routes, travelers, and procedures within PLM systems.
• Coordinate new asset commissioning and manufacturing readiness activities.
• Collaborate with Operations, Engineering, Quality, Planning, and OpEx teams.
• Work with OEM equipment manufacturers to define user requirements.
• Ensure compliance with FDA regulations and quality system requirements.
• Prepare technical reports, presentations, and manufacturing documentation.
• Support continuous improvement and process optimization initiatives.

Skills

Manufacturing Engineering

Process Validation

IQ/OQ/PQ Protocols

Medical Device Experience

Root Cause Analysis

Technical Documentation

FDA Compliance

Process Engineering

PLM Systems

Microsoft Office

Education

Bachelor's degree in Engineering or related discipline preferred

2-4 years manufacturing or process engineering experience

Tools

Minitab

Statistical analysis tools

Job description

VOLTO Consulting is seeking a Manufacturing Engineer in Raynham, MA to support process development, validation, and production readiness in a regulated medical device environment.

The role emphasizes hands‑on IQ/OQ/PQ, process engineering, and cross‑functional collaboration with Operations, Quality, Planning, and Engineering teams to drive continuous improvement and compliance with FDA requirements.