Assembler, Manufacturing ​/ Production

This role involves precise, microscope-assisted manufacturing of neurovascular catheters used in stroke treatments. You will work in a cleanroom environment performing intricate multi-stage builds, conducting detailed quality inspections, and strictly following FDA and ISO medical device regulations to ensure every product meets exacting medical standards.

• Perform precision assembly of neurovascular catheters using microscopes and small hand tools such as tweezers, cutters, and pliers.
• Execute complex multi-stage builds, including liner stretching, coil winding, braiding, balloon bonding, flaring, and reflow processes.
• Carry out continuous visual inspections under a microscope to identify defects and verify that catheters meet defined medical specifications.
• Follow Standard Operating Procedures (SOPs), FDA Quality System Regulations (QSR), and relevant ISO standards at all times.
• Maintain accurate and complete production documentation for each build and process step.
• Prepare and package finished medical devices correctly for downstream sterilization processes.
• Work consistently in a cleanroom or controlled environment room (CER), maintaining cleanliness and contamination control protocols.
• Use both mechanical and electrical assembly techniques as required for medical device manufacturing.
• Collaborate with team members and quality personnel to address issues, support continuous improvement, and maintain high product quality.
• Handle small components with high manual dexterity and care to avoid damage and ensure precise assembly.
• Follow inspection and testing procedures to confirm device functionality and compliance with specifications.

• 1 to 3 years of recent catheter or medical device assembly experience.
• Proven experience with microscope-assisted assembly work.
• Strong manual dexterity and the ability to handle very small components accurately.
• High visual acuity to perform continuous inspections under a microscope.
• Ability to use small hand tools such as tweezers, cutters, and pliers for precision assembly.
• Experience working in a cleanroom or controlled environment room (CER).
• Familiarity with Standard Operating Procedures (SOPs).
• Knowledge of FDA Quality System Regulations (QSR).
• Knowledge of ISO standards relevant to medical device manufacturing.
• Ability to sit or stand for extended periods while performing repetitive, detailed tasks under a microscope.
• Capability to follow detailed written and verbal instructions and maintain accurate records.
• Commitment to quality, safety, and compliance in a regulated environment.

• Experience in medical assembly, including neurovascular or other catheter-based devices.
• Experience in mechanical assembly and basic electrical assembly for medical devices.
• Experience with braiding, coil winding, and other advanced catheter manufacturing techniques.
• Prior work in cleanroom environments with strict contamination control procedures.
• Comfort with inspection assembly processes and quality-focused workflows.
• Bilingual communication skills.

You will join a team that supports your long-term well-being through comprehensive health insurance for you and your dependents, along with direct coverage for routine dental care. The company offers life insurance options that provide additional financial security, as well as an employer-sponsored 401(k) plan to help you build your retirement savings. You will benefit from paid time off and paid holidays, supporting a healthy work-life balance and giving you time to rest and recharge.

You will work in a cleanroom or controlled environment room (CER) dedicated to medical device manufacturing. This setting requires strict adherence to cleanliness and contamination control procedures and involves wearing specific protective gowning, including smocks, hair nets, and safety glasses. The role requires extended periods of sitting or standing while continuously using a microscope and handling small components with precision. The environment is structured, highly regulated, and focused on quality, with established SOPs, FDA QSR, and ISO standards guiding daily operations.

This is a Contract to Hire position based out of Miami, FL.

The pay range for this position is $20.00 - $23.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job…