Assembler - 2nd Shift
$21 - $24.15 per hourAerotek
Job Description Job Description Job Title: Assembler (2nd Shift) Job Description This role focuses on the precise assembly of medical devices, including catheter products, using a microscope in a regulated cleanroom manufacturing environment. You will follow established procedures and documentation standards to ensure product quality, safety, and compliance with industry regulations while supporting production and process development activities. Responsibilities
- Manufacture medical devices, including catheter assemblies, under a microscope with a high level of accuracy and hand dexterity.
- Follow and adhere to Standard Operating Procedures (SOPs), Line Clearance requirements, Work Instructions, assembly methods, product handling methods, production drawings, Good Documentation Practices, current Good Manufacturing Practices (cGMP), and all safety requirements.
- Successfully complete training on production tasks and apply that knowledge to daily work.
- Read and understand travelers/routers, correctly identify materials, and use production and inspection tools and equipment needed for product builds.
- Operate manufacturing tools and equipment and complete all required documentation in a timely and accurate manner.
- Perform equipment set-up, operation, and in-process inspection to accomplish assigned tasks and maintain product quality.
- Work directly with engineers and supervisors to ensure product integrity and quality standards are consistently met.
- Collaborate with engineers to develop and refine process documentation for manufacturing operations.
- Perform inventory counts and support material control activities as needed.
- Use adhesives, including various Loctite products, with EFD dispensers and UV curing systems during assembly processes.
- Carry out cleanroom production activities while maintaining cleanliness and contamination control standards.
- Conduct in-process inspection to verify workmanship and quality of in-process medical devices.
- Receive and follow verbal instructions regarding duties to be performed and complete other related tasks as assigned.
- Minimum of 6 months of experience in a regulated manufacturing environment.
- Hands-on experience in a manufacturing or production environment, or prototyping experience.
- Prior experience with microscope-based assembly work.
- Prior experience in medical device assembly, particularly small, intricate components.
- Prior cleanroom experience and ability to follow cleanroom protocols.
- Ability to understand and perform in-process inspection to ensure workmanship and quality of medical devices.
- Strong hand dexterity and fine motor skills for detailed assembly tasks.
- Ability to follow SOPs, Work Instructions, and cGMP requirements accurately.
- Effective communication skills to work with engineers, supervisors, and team members.
- Ability to use required safety equipment when performing lab and production work.
- Experience in manufacturing catheter products is a plus.
- Familiarity with Line Clearance procedures and Good Documentation Practices.
- Experience working with adhesives, including different Loctite products.
- Knowledge of using EFD dispensers and UV curing systems in production.
- Background in inspection activities within a manufacturing or medical device environment.
- Comfort working in a startup environment with evolving processes and documentation.
$21 - $24.15 per hour
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