Manufacturing Engineer - Medical Device

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

About The Role

We are seeking a Manufacturing Engineer with experience in medical device or regulated manufacturing environments to support manufacturing process development, validation, and production readiness activities. The ideal candidate will have hands‑on experience with validation protocols, process engineering, equipment commissioning, and cross‑functional collaboration in a highly regulated environment.

We are seeking a Manufacturing Engineer with experience in medical device or regulated manufacturing environments to support manufacturing process development, validation, and production readiness activities. The ideal candidate will have hands‑on experience with validation protocols, process engineering, equipment commissioning, and cross‑functional collaboration in a highly regulated environment.

This role requires strong technical writing skills, process validation expertise, and the ability to support manufacturing operations, quality initiatives, and continuous process improvements.

Key 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

Required 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

Preferred Qualifications

• Experience with machining or metal finishing processes
• Laser processing or automation experience
• Knowledge of Minitab and statistical analysis tools
• Understanding of GD&T principles
• Experience working in regulated manufacturing environments
• Ability to support global projects and travel as required

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

Preferred Industry Experience

• Medical Devices
• Regulated Manufacturing
• Production Automation
• Manufacturing Operations