Manufacturing Engineering Support
Katalyst HealthCares & Life Sciences
Manufacturing Engineering Support / Ethicon Project Support Engineer
The Manufacturing Engineering Support / Ethicon Project Support Engineer will support the development, testing, validation, and production readiness of medical device components and equipment.
The role involves executing and documenting test configurations, supporting equipment installation and debugging, maintaining manufacturing documentation, and collaborating with suppliers and operations teams to ensure smooth production transitions.
The engineer will also assist in process development, qualification activities, inventory management, and training support within a regulated medical device manufacturing environment.
Roles And Responsibilities:
- Set up, execute, and document test configurations for components and equipment.
- Develop, refine, and improve test procedures and protocols to enhance testing efficiency and reliability.
- Build, maintain, and operate prototype and production equipment.
- Support installation, startup, debugging, validation, and qualification of new products and manufacturing equipment.
- Collaborate with suppliers, engineering, and operations teams to ensure equipment meets specifications and transitions smoothly into production.
- Maintain and update detailed technical documentation including test results, SOPs, component specifications, and validation records.
- Provide onboarding, training, and technical support to testing and process personnel.
- Manage equipment and component inventory, procurement, and delivery tracking.
- Support process development and qualification activities for components, assembly processes, and software-driven systems.
- Ensure compliance with medical device regulations, quality standards, and manufacturing engineering best practices.
Experience:
- 4–6 years of experience in Manufacturing Engineering Support, preferably within the medical device industry.
- Experience supporting Ethicon or similar regulated medical device manufacturing projects is preferred.
- Strong understanding of medical device regulations, validation processes, and manufacturing documentation practices.
- Experience with equipment testing, troubleshooting, process qualification, and SOP development.
- Ability to work collaboratively with cross-functional teams, suppliers, and production personnel.
- Strong analytical, documentation, communication, and problem-solving skills.
Education:
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Electrical Engineering, or a related technical field.
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