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