Assembler

Medical Device Assembler Catheters (Cleanroom)

This role focuses on assembling and packaging catheter-based medical devices in a controlled cleanroom environment. You will work with small components under a microscope, use precision hand tools, operate specialized equipment, and follow strict quality and documentation standards in an FDA-regulated facility.

Shift: Swing shift: 2:45 p.m-11:15pm

Pay rate: $20-24 (+10% diff)

Responsibilities

• Assemble catheter medical devices using small hand tools such as tweezers and razors with a high level of precision.
• Process and handle very small parts under a microscope to build and inspect catheter components.
• Adhere to all company Quality Policies and Systems, including Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Maintain accurate and complete records, including Lot History Records (LHR), ensuring all documentation meets regulatory and internal standards.
• Follow Manufacturing Process Instructions (MPI) and standard operating procedures for all tasks.
• Flex and rotate between different workstations, including catheter assembly lines and packaging lines, as business needs require.
• Apply 5S principles to maintain an organized, clean, and efficient work area.
• On the catheter line, cut and trim catheters to specification using appropriate tools and equipment.
• Operate balloon blowing machines to form and integrate balloons into catheters according to defined parameters.
• Work with plastic tubing, guidewires, and sheaths, aligning and layering components under a microscope to meet assembly specifications.
• Perform UV curing and use hot boxes as part of the catheter assembly process, following all safety and process guidelines.
• On the packaging line, work with ovens and refrigerators to prepare hydrogel used in catheter products.
• Package catheters into plastic packaging, including accurately adding hydrogel into the catheter as required.
• Comply with all cleanroom and Controlled Environment Room requirements, including gowning and contamination control procedures.
• Communicate clearly and professionally with supervisors, peers, and auditors, including responding to questions from regulatory bodies when needed.
• Support inventory control by accurately counting, recording, and tracking materials and components used in production.
• Contribute to continuous improvement by following best practices and identifying opportunities to enhance quality, safety, and efficiency.

Why Work Here?

You will join an established medical device manufacturer that offers an excellent entry point into the industry, along with strong benefits and long-term stability. Once converted to a permanent role, employees receive comprehensive benefits coverage, a 401(k) match, paid time off, sick time, and eight paid holidays. The organization emphasizes quality, regulatory compliance, and professional growth, providing a structured environment where you can build valuable skills in cleanroom production and FDA-regulated processes.

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 $19.00 - $25.00/hr. 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 Jul 11, 2026.