Medical Device Assembler (Any Experience)

Entry Level Medical Device Assembler Catheter ProductionThis role focuses on the precise assembly and packaging of catheter-based medical devices in a controlled, FDA-regulated cleanroom environment. You will work with small components under a microscope, use fine hand tools, and follow detailed manufacturing procedures to ensure every product meets strict quality and regulatory standards.ResponsibilitiesAssemble catheter medical devices using small hand tools such as tweezers and razors while maintaining high levels of accuracy and consistency.Process and handle small parts under a microscope, including catheter tubes, guidewires, sheaths, and related components.Adhere to all company Quality Policies and Systems, including Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Manufacturing Process Instructions (MPI).Maintain accurate and complete records, including Lot History Records (LHR), ensuring all documentation is legible, timely, and compliant with regulatory expectations.Operate balloon blowing machines to form balloons in catheters, monitoring equipment and processes to ensure proper function and product quality.Cut and trim catheters to specification, ensuring clean, precise cuts and proper dimensions.Align and layer plastic tubing and guidewires/sheaths under the microscope, ensuring correct placement and orientation according to procedures.Perform UV curing and use hot boxes as part of catheter assembly and finishing processes, following safety and process guidelines.Work on the packaging line, including operating ovens and refrigerators to prepare hydrogel and ensuring correct preparation and handling.Package catheters in plastic packaging and accurately add hydrogel into the catheter as required by the process.Follow and adhere to 5S principles and goals to maintain an organized, efficient, and safe work area.Flex and rotate between different stations, including catheter line and packaging line, as business needs require.Communicate clearly and professionally, including responding to questions from regulatory bodies such as the FDA if needed.Demonstrate accurate reading, writing, math, and inventory control skills to support production counts, documentation, and material tracking.Essential SkillsExperience in catheter medical device assembly or medical device packaging.Hands-on experience working under a microscope with small parts such as catheter tubes or stents.Ability to work in a Controlled Environment Room and comply with cleanroom protocols.Strong handeye coordination to handle delicate components and perform fine assembly tasks.Good verbal and written communication skills to complete Lot History Records (LHR) and other documentation accurately.Capability to communicate effectively with internal teams and respond to regulatory inquiries when required.Demonstrated reading, writing, and basic math skills to support accurate counts and inventory control.Knowledge and practical application of GMP, GDP, and following Manufacturing Process Instructions (MPI).Comfort using small hand tools such as tweezers and razors in a production environment.Ability to follow detailed work instructions and quality procedures consistently.Additional Skills & QualificationsPrior experience in a medical device cleanroom or FDA-regulated manufacturing environment.Background in assembly, production, or packaging roles, especially within medical device manufacturing.Familiarity with 5S principles and continuous improvement practices.Experience operating production equipment such as balloon blowing machines, ovens, UV curing equipment, and hot boxes.Exposure to working with hydrogel or similar materials in a production setting.Comfort rotating between multiple stations and tasks within a production line.Why Work Here?You will join an entry-level friendly medical device manufacturer where you can build a meaningful career working on life-improving products. The organization offers comprehensive benefits once converted, including full coverage of benefits, a 401(k) match, paid time off, sick time, and eight paid holidays. You will gain hands-on experience in an FDA-regulated environment, develop valuable technical skills, and work in a setting that emphasizes quality, safety, and professional growth.Work EnvironmentThis position is based in a medical device, FDA-regulated cleanroom and Controlled Environment Room, where you will follow strict cleanliness, GMP, and GDP standards. You will work with microscopes, small hand tools, balloon blowing machines, UV curing equipment, hot boxes, ovens, refrigerators, and other production and packaging equipment. The role follows a five-day workweek with multiple shifts available: a day shift (generally starting between 5:30 a.m. and 6:00 a.m.) and a swing shift (typically starting between 2:15 p.m. and 2:45 p.m.), with the swing shift offering a 10% differential. The environment emphasizes organization and efficiency through 5S principles, and you will wear appropriate cleanroom attire as required to maintain product and environmental integrity.Job Type & LocationThis is a Contract to Hire position based out of Santa Clara, CA.Pay and BenefitsThe 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) Aerotek