Assembler

Hiring Medical Device Assemblers In Santa Clara, Open To All Experience LevelsJob Title: Medical Device Catheter Assembly TechnicianThis role focuses on assembling and packaging catheter-based medical devices in a controlled, FDA-regulated cleanroom environment. You will work with very small components under a microscope, use precision hand tools, follow detailed manufacturing instructions, and maintain accurate documentation in compliance with GMP, GDP, and quality system requirements.Responsibilities:Perform catheter medical device assembly, including working with small parts such as catheter tubes, guidewires, sheaths, stents, and plastic tubing under a microscope.Use small hand tools such as tweezers and razors to cut, trim, align, and assemble catheter components with high precision.Operate balloon blowing machines to form and integrate balloons into catheters according to manufacturing process instructions.Perform UV curing and use hot boxes as part of the catheter assembly and bonding process.Work on the catheter line to cut and trim catheters, align and layer tubing and guidewires under the microscope, and ensure assemblies meet quality standards.Work on the packaging line to prepare hydrogel using ovens and refrigerators, and apply hydrogel to catheters as required.Package finished medical devices in plastic packaging, ensuring proper labeling, sealing, and documentation in accordance with GMP/GDP policies.Adhere to all Quality Policies and Systems, including Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Manufacturing Process Instructions (MPI).Maintain accurate records such as Lot History Records (LHR), ensuring all entries are complete, legible, and compliant with regulatory and company standards.Follow 5S principles and goals to maintain a clean, organized, and efficient work area within the cleanroom and controlled environment room.Flex and rotate to different workstations on the catheter line and packaging line as needed to support production requirements.Communicate clearly and professionally in writing and verbally, including the ability to respond to regulatory inquiries if required.Demonstrate accurate reading, writing, math, and inventory control skills to support material counts, documentation, and production tracking.Consistently follow controlled environment and cleanroom protocols, including gowning procedures and handling of materials and equipment.Meet production, quality, and safety standards while working on day or swing shifts in a fast-paced, regulated manufacturing environment.Essential Skills:Experience in catheter medical device assembly or medical device packaging.Proficiency in working under a microscope with small parts such as catheter tubes, guidewires, sheaths, or stents.Ability to use small hand tools (e.g., tweezers, razors) for precise assembly and trimming of components.Strong handeye coordination for handling and assembling very small parts accurately.Ability to work in a Controlled Environment Room and FDA-regulated cleanroom setting.Excellent written and verbal communication skills for completing Lot History Records (LHR) and other documentation, and for communicating with regulatory representatives if required.Demonstrated reading, writing, and basic math skills, including accurate inventory control and counting.Understanding and application of GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), and following MPI (Manufacturing Process Instructions).Ability to follow detailed procedures, quality policies, and 5S principles consistently.Comfort working with production and packaging processes in a medical device environment.Additional Skills & Qualifications:Prior experience in a medical device cleanroom or FDA-regulated manufacturing environment.Familiarity with catheter lines, balloon blowing machines, UV curing, and hot box operations.Experience preparing and handling hydrogel and working with ovens and refrigeration equipment in a production setting.Ability to flex between assembly and packaging stations based on production needs.Strong attention to detail and ability to maintain high accuracy in documentation and product quality.Reliability and flexibility to work day or swing shifts, including early start or late end times as required.Why Work Here?This opportunity offers a strong entry point into the medical device industry, providing hands-on experience with life-impacting catheter products in a structured and supportive environment. Once converted to direct hire, employees receive comprehensive benefits with full coverage, a 401(k) match, paid time off, sick time, and eight paid holidays. The organization promotes stability, growth, and skill development, creating a workplace where attention to quality and continuous improvement are valued and recognized.Work Environment:You will work in an FDA-regulated medical device cleanroom and Controlled Environment Room, following strict GMP, GDP, and 5S standards. The role involves day and swing shift options: day shift generally runs from approximately 5:306:00 a.m. to mid-afternoon, and swing shift typically runs from approximately 2:152:45 p.m. to late evening, with a shift differential for swing. The environment includes working under microscopes, using small hand tools, operating balloon blowing machines, UV curing equipment, hot boxes, ovens, and refrigeration units. Cleanroom protocols, including appropriate gowning and hygiene practices, are required to maintain product safety and regulatory compliance.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 16, 2026.