Assembler, Atia Vision

ShifaMed • Campbell, CA

354d • $58,000 - $67,000

About The Position

Atia Vision, a Shifamed Portfolio Company, is dedicated to enhancing patient outcomes by developing a safe and controllable presbyopia correcting IOL aimed at restoring the full range of functional vision in cataract patients, the largest segment of the ophthalmology market. This position is responsible for the manufacturing and inspection of medical devices for operations and R&D. The role may involve assisting in the development of the manufacturing process for lean flow and process improvements. The position is part of a small manufacturing and R&D team with daily interactions with engineers and technicians. This is a full-time on-site position requiring reporting to our offices located in Campbell, CA.

Requirements

• High School diploma (AA degree preferred) or equivalent experience in a technical discipline.
• Minimum of 5 years of experience in medical device or similar product design and/or manufacturing (3 years with AA).
• Experience with 5S manufacturing.
• Experience with medical device manufacturing including following good manufacturing practice (GDP).

Responsibilities

• Follow Manufacturing Process Instructions (MPIs) to build and inspect medical devices.
• Fill out design history files (DHR) as required.
• Apply adhesives to small components using needles, EFD dispensers, and syringes.
• Learn and operate transfer press molding machines.
• Clean components and labware using ultrasonic cleaners, autoclaves, and ovens.
• Trim and inspect small parts using small hand tools under a microscope.
• Perform manufacturing inspections under a microscope.
• Work on several different batches at different manufacturing processes throughout the day.
• Communicate and document issues and observations with supervisor and engineers.
• Comply with production control requirements including environmental controls, CER requirements, hygiene, documentation, and procedural compliance.
• Document any deviations to written instructions in accordance with quality systems requirements.
• Support the Quality System and Quality Policy.
• Perform job functions in a safe and effective manner.
• Demonstrate fine dexterity for assembling small components and good attention to detail.
• Understand GMP and Clean room procedures and behavior.
• Use tools and measurement devices effectively.
• Operate automated equipment as needed.
• Communicate issues or observations clearly and document activities accurately.
• Work collaboratively as a team player.

Benefits

• Base salary range of $58,000 to $67,000 based on experience and qualifications.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED