Assembler

Catheter Assembly TechnicianThis role focuses on the precise assembly and packaging of catheter-based medical devices in a controlled, FDA-regulated cleanroom environment. You will work with very small components under a microscope, use fine hand tools, and operate specialized equipment to build and package high-quality catheters in strict accordance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and established manufacturing procedures.Responsibilities:Assemble catheter medical devices using small hand tools such as tweezers and razors with a high level of precision and care.Process and handle small parts, including plastic tubing, guidewires, and sheaths, under a microscope to align, layer, and assemble components accurately.Cut and trim catheters to specification on the catheter line, ensuring consistency and adherence to quality standards.Operate balloon blowing machines to form and integrate balloons into catheters, monitoring equipment performance and product quality.Perform UV curing and hot box operations as part of the catheter assembly process, following all safety and process guidelines.Work on the packaging line to prepare hydrogel using ovens and refrigeration equipment, ensuring correct formulation and handling.Package catheters in plastic packaging and accurately add hydrogel to the devices according to defined procedures.Maintain accurate and complete Lot History Records (LHR) and other production documentation, following all GMP and GDP requirements.Adhere to all company quality policies, systems, and manufacturing process instructions (MPI), ensuring compliance with FDA-regulated standards.Follow and support 5S principles to maintain an organized, clean, and efficient work area within the cleanroom.Flex and rotate between different stations, including catheter line and packaging line, as production needs require.Demonstrate strong reading, writing, math, and inventory control skills to ensure accurate counts, documentation, and material tracking.Communicate clearly and professionally regarding production processes and documentation, including the ability to respond to regulatory inquiries if needed.Consistently follow controlled environment room protocols, including gowning, cleanliness, and handling procedures for medical devices.Logistics:Day Shift / Swing Shift$22+Job Type & Location:This is a Contract to Hire position based out of Santa Clara, CA.Pay and Benefits:The pay range for this position is $21.00 - $26.40/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)Workplace Type:This is a fully onsite position in Santa Clara, CA.Application Deadline:This position is anticipated to close on Oct 1, 2026.