Manufacturing Engineer - Medical Device

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.

• 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

• Manufacturing Engineering
• Process Validation
• IQ/OQ/PQ Protocols
• Medical Device Experience
• Root Cause Analysis
• Technical Documentation
• FDA Compliance
• Process Engineering
• PLM Systems
• Microsoft Office

• 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

• 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

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