What are the responsibilities and job description for the Cleanroom Operator Hiring Multiple Candidates position at Lenkbar | an Intech company?
About The Company
Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.
Here at Lenkbar we give our customers the competitive edge in today's highly specialized design and development of cutting tools. We assist with the design and production of a variety of drills, burrs and taps for the orthopedic industry and world class flexible shafts to meet our customers' most demanding requirements. From Swiss turning to precision grinding, we leverage advanced machining techniques and best-in-class equipment that are automated and optimized for performance to support our customers' next critical product launch.
Job Description
We are seeking for a multiple dedicated Cleanroom Operators to join our medical device manufacturing team. This role is responsible for operating, monitoring, and maintaining production equipment in a controlled cleanroom environment, ensuring all medical devices meet strict quality and regulatory standards. The ideal candidate has strong attention to detail, follows procedures meticulously, and thrives in a fast-paced, high-precision manufacturing setting.
Key Responsibilities
Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.
Here at Lenkbar we give our customers the competitive edge in today's highly specialized design and development of cutting tools. We assist with the design and production of a variety of drills, burrs and taps for the orthopedic industry and world class flexible shafts to meet our customers' most demanding requirements. From Swiss turning to precision grinding, we leverage advanced machining techniques and best-in-class equipment that are automated and optimized for performance to support our customers' next critical product launch.
Job Description
We are seeking for a multiple dedicated Cleanroom Operators to join our medical device manufacturing team. This role is responsible for operating, monitoring, and maintaining production equipment in a controlled cleanroom environment, ensuring all medical devices meet strict quality and regulatory standards. The ideal candidate has strong attention to detail, follows procedures meticulously, and thrives in a fast-paced, high-precision manufacturing setting.
Key Responsibilities
- Demonstrate safety as a core value and establish a safe work environment.
- Follow all quality and operating requirements.
- Operate and monitor manufacturing equipment within a cleanroom environment.
- Follow standard operating procedures (SOPs), work instructions, and Good Manufacturing Practices (GMP).
- Assemble, inspect, and package medical devices according to strict quality standards.
- Maintain compliance with ISO 13485 and FDA regulations.
- Perform in-process quality checks and document results accurately.
- Handle raw materials and components while maintaining sterility requirements.
- Clean and sanitize workstations, equipment, and tools as per cleanroom protocols.
- Report equipment malfunctions and deviations to supervisors or engineers.
- Collaborate with quality assurance and production teams to resolve issues.
- Ensure proper labeling and documentation of all production activities.
- Ability to operate various manufacturing equipment, follow specific direction, operate power hand tools, and other duties as assigned.
- Maintain a clean work environment.
- Ability to read a tape measure and have basic math and computer skills.
- Ability to work safely and comply with all safety regulations.
- Ability to wear cleanroom attire (gown, gloves, mask) for the duration of the shift.
- Ability to lift, push or pull 50lbs, navigate stairs, stand, walk, bend, and kneel throughout the entire shift.
- High school diploma or equivalent
