Assembler, Manufacturing ​/ Production

Assembler

This role involves precise, microscope-assisted assembly of neurovascular catheters used in stroke treatments within a cleanroom environment. You will perform intricate builds, conduct detailed quality inspections, and strictly follow FDA and ISO medical device regulations to ensure every product meets exacting clinical standards.

• Perform detailed manual and complex multi-stage catheter assemblies using small hand tools such as tweezers, cutters, and pliers in conjunction with microscopes.
• Execute advanced manufacturing techniques, including liner stretching, coil winding, braiding, balloon bonding, flaring, and reflow processes, following established procedures.
• Carry out continuous visual inspections of components and finished catheters under magnification to identify defects and verify adherence to precise medical specifications.
• Conduct testing of catheters as required to confirm functional performance and compliance with quality requirements.
• Strictly adhere to Standard Operating Procedures (SOPs), FDA Quality System Regulations (QSR), and applicable ISO standards throughout all stages of assembly and inspection.
• Maintain accurate, legible, and complete production records, including documentation of inspection results and process steps.
• Ensure final medical devices are properly packaged and prepared for sterilization in accordance with documented procedures.
• Work consistently in a controlled environment room (CER) or cleanroom, following all gowning, cleanliness, and contamination-control protocols.
• Collaborate with team members and leads to identify and communicate quality or process issues and support continuous improvement efforts.
• Handle and assemble mechanical and electrical components related to medical devices with high attention to detail and safety.

• Generally requires 1 to 3 years of recent catheter or medical device assembly experience.
• Demonstrated experience performing precision assembly work using microscopes and small hand tools such as tweezers, cutters, and pliers.
• Proficiency working in a cleanroom or controlled environment room (CER) and following cleanroom protocols.
• Strong manual dexterity and fine motor skills for handling small components and intricate assemblies.
• High visual acuity and the ability to perform continuous microscope-based inspection and assembly.
• Ability to sit or stand for extended periods while performing repetitive, detailed tasks under a microscope.
• Experience following Standard Operating Procedures (SOPs) and working within FDA Quality System Regulations (QSR) and ISO standards.
• Ability to perform inspection and quality control activities, including visual inspection and documentation of results.
• Experience with mechanical assembly in a regulated manufacturing environment.
• Bilingual communication skills.

• Experience in medical device assembly, particularly neurovascular or catheter-based products.
• Familiarity with advanced assembly techniques such as liner stretching, coil winding, braiding, balloon bonding, flaring, and reflow processes.
• Experience in electrical or electro-mechanical assembly related to medical devices.
• Comfort working with highly detailed documentation and production records.
• Ability to understand and follow technical instructions and quality standards.
• Strong focus on precision, quality, and consistency in a highly regulated environment.

Employees benefit from comprehensive health insurance that includes medical coverage for both themselves and their dependents, as well as direct dental care coverage for routine checkups and procedures. The organization supports long-term financial security through an employer-sponsored 401(k) plan and provides life insurance options that are fully or partially company-sponsored. A generous package of paid time off and holidays supports work-life balance and allows employees to rest and recharge.

Overall, the company offers a stable, supportive environment with strong benefits designed to promote employee well-being and long-term career satisfaction.

You will work in a cleanroom or controlled environment room…