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Manufacturing Engineer - Medical Device

Volto USA

Raynham, MA

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JOB DETAILS
SALARY
$45–$55
SKILLS
Automation, Commissioning, Commissioning - Engineering, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Documentation, Engineering, FDA (Food and Drug Administration), FDA Requirements, Geometric Dimensioning and Tolerancing, Interpersonal Skills, Machining, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Operations, Manufacturing Process Engineering, Manufacturing Requirements, Manufacturing/Industrial Processes, Medical Equipment, Microsoft Office, Minitab, OEM (Original Equipment Manufacturer), Operational Expenditure (OPEX), Operational Support, Process Development, Process Engineering, Process Improvement, Process Validation, Product Lifecycle Management, Quality Assurance, Quality System Requirements (QSR), Regulatory Compliance, Reporting Skills, Requirements Management, Root Cause Analysis, Statistics, Technical Presentation, Technical Writing, Validation Plan, Willing to Travel, Writing Skills
LOCATION
Raynham, MA
POSTED
3 days ago
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

About the Company

V

Volto USA