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. 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
• 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

• Mechanical Engineering or related discipline
• Experience with validation protocols, process engineering, and equipment commissioning
• Hands-on experience in medical device or regulated manufacturing environments
• Experience with process validation, IQ/OQ/PQ protocols, and root cause analysis
• Strong technical writing and communication skills
• Experience with 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