United Consulting Hub is seeking a Manufacturing Engineer to support manufacturing and process improvement activities within a medical device environment. This role involves assisting with production documentation, validation support, and manufacturing process activities while ensuring compliance with quality and regulatory standards.
Responsibilities:
- Support development and update of manufacturing work instructions and procedures
- Assist with process validation activities including IQ/OQ/PQ
- Participate in manufacturing documentation and remediation activities
- Support risk assessment and control plan activities
- Collaborate with Quality, Validation, and Manufacturing teams
- Assist with root cause investigations and CAPA activities
- Support equipment and production process improvement initiatives
- Maintain compliance with GMP, ISO, and regulatory requirements
Requirements:
- Bachelor's degree in Mechanical, Industrial, Manufacturing, Biomedical, Electrical Engineering, or related field
- 0–2 years of experience in manufacturing, validation, or medical device environments
- Basic understanding of IQ/OQ/PQ and manufacturing processes
- Strong communication and problem-solving skills
- Ability to work in a fast-paced team environment
- Familiarity with GMP, ISO 13485, or FDA regulations