Our global medical device client who is dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease is in need of multiple Operators/Medical Assemblers.
This individual would be responsible for assembling high quality medical devices in accordance with approved manufacturing process instructions and Standard Operating Procedures, assisting in the evaluation and resolution of line issues, and suggesting possible method / process improvements. Other job duties will be assigned as needed.
Duties
- Adhere to safety rules, stretching exercises, and company policies and procedures.
- Assemble product as required utilizing small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
- Identify and communicate any safety, quality, process issues or concerns as needed.
- Maintain controlled environment integrity by using proper attire and adherence to controlled environment practices and procedures.
- Perform in-process quality checks as required while giving timely feedback as issues arise
- Recognize and report any unacceptable materials and/or sub-assemblies to engineering and/or supervisor.
- Responsible for quality of work and adhering to manufacturing methods and quality records.
- Understand and comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Work with supervisors, engineers and technicians to resolve line issues and suggest improvements.
- Participate in lean activities and 5S improvement efforts.
- Be familiar with terminology used in the production area.
- Aware of common defects within manufacturing departments and the results caused by variations during the manufacturing processes.
- Capable of moving from one station to another without continuous mistakes.
- May be certified as a trainer and train other production employees on manufacturing processes.
- Capability to read and interpret engineering drawings, specs and method sheets.
- Electronic systems entry
Education
- High School Diploma or equivalent
- Demonstrates basic English reading, writing and spoken skills
- Basic math
Experience
- Minimum of 1 year of Manufacturing Experience (Medical Device Preferred)
- Work with small components, adhesives, and microscopes
- Experience working within a clean room environment