Entry Level Medical Device Assembler

OperatorThe Operator performs hands-on assembly work in a cleanroom environment to support the manufacture of balloon catheters and related delivery systems. This role combines routine, detail-oriented production tasks with accurate documentation, basic machine operation, and adherence to Good Manufacturing Practices (GMP). The Operator contributes to efficient product flow by following work instructions, completing operation steps in the manufacturing execution system, and helping maintain high service levels and minimal delays in production.Responsibilities:Perform assembly work that involves fitting, alignment, and adjustment of parts in a cleanroom environment.Carry out simple and routine tasks in the preparation of balloon catheters and supporting systems according to established procedures.Check and follow documentation and work instructions to ensure correct setup and operation of equipment.Set up machines, load 12 components into the machine, perform quick visual inspections, and unload the machine upon completion of cycles.Read and review customer specifications and work instructions to ensure all product requirements are met.Review documents and complete required forms neatly, legibly, and accurately.Perform tasks related to the manufacture of textiles as required by production needs.Take direction from supervision and complete assigned tasks independently and on time.Enter transactions in the Epicor MES system as operations are completed to maintain accurate production records.Complete operation step confirmations in the manufacturing execution system to track progress and ensure traceability.Apply Good Manufacturing Practices (GMP), documentation standards, and cleanroom requirements consistently throughout all work activities.Support production planning and inventory control activities for multiple products as directed.Prioritize operations to help ensure maximum performance and minimum delay in the manufacturing process.Contribute to continuous improvement efforts focused on product flow and capacity improvement to enhance overall manufacturing efficiency.Essential Skills:At least 1 year of assembly experience in a manufacturing or similar environment.Familiarity with working in a cleanroom environment and following cleanroom protocols.Ability to understand and apply Good Manufacturing Practices (GMP) and cleanroom requirements.Ability to read and interpret customer specifications, work instructions, and production documentation.Ability to read measuring devices accurately to verify product dimensions and quality.Ability to read and write clearly to complete forms and production records.Ability to perform basic math functions to support measurements, counts, and documentation.Capability to complete assigned tasks independently while following supervisory direction.Attention to detail for visual inspection of components and assemblies.Basic machine operation skills for loading, running, and unloading production equipment.Additional Skills & Qualifications:Experience with cleanroom assembly involving catheters, stents, or other medical device components.Familiarity with Epicor MES or similar manufacturing execution systems for entering transactions and confirming operation steps.Understanding of documentation practices in regulated manufacturing environments.Comfort working with textiles or related materials used in manufacturing processes.Interest in supporting continuous improvement initiatives related to product flow and capacity.Why Work Here?You join a medical device manufacturing environment that values precision, quality, and adherence to established processes.The team-oriented culture emphasizes clear communication, reliable documentation, and continuous improvement, offering opportunities to grow your skills in cleanroom assembly and manufacturing systems.Working here allows you to contribute to products that support healthcare while gaining experience in a structured, process-driven environment.Work Environment:This role is based in a cleanroom environment within a medical device manufacturing facility that produces balloon catheters and their delivery systems as a contract manufacturer.Work is performed on 2nd shift and involves standing at or near production equipment, handling small components, and operating machines for loading, inspection, and unloading tasks.Team members follow Good Manufacturing Practices (GMP), cleanroom protocols, and detailed documentation requirements, using Epicor MES and measuring devices as part of daily work.The environment is structured, process-driven, and focused on maintaining product quality and consistent production flow.Job Type & Location:This is a Contract position based out of Laguna Niguel, CA.Pay and Benefits:The pay range for this position is $20.50 - $20.50/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)Application Deadline:This position is anticipated to close on Oct 28, 2026.Workplace Type:This is a fully onsite position in Laguna Niguel, CA.