Medical Device Manufacturing Engineer – Process Validation

VOLTO Consulting; Raynham (MA); In loco; USD 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Manufacturing Engineering

Process Validation

IQ/OQ/PQ Protocols

Medical Device Experience

Root Cause Analysis

Technical Documentation

FDA Compliance

Process Engineering

PLM Systems

Microsoft Office

Formazione

Bachelor's degree in Engineering or related discipline preferred

2-4 years manufacturing or process engineering experience

Strumenti

Minitab

Statistical analysis tools

Descrizione del lavoro

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.

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.

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